MedPath

A Causal Role for Voltage-gated Cav1.2 Calcium Channels in Mediating 5G FR1 Effects on Sleep-associated Brain Health in Humans

Not Applicable
Recruiting
Conditions
Mediation of 5G Effects on Sleep
Interventions
Radiation: 5G RF-EMF
Registration Number
NCT06998368
Lead Sponsor
Hans-Peter Landolt
Brief Summary

Electromagnetic fields (EMFs) generated by the use of 5G technology influence certain sleep characteristics, especially in individuals carrying a specific genetic variant of a protein in the brain that regulates the activity of nerve cells. This protein is a voltage-gated calcium channel called CaV1.2 and could be involved in the effects of 5G technology on sleep. The calcium channel CaV1.2 can be selectively blocked by the drug nimodipine.

To demonstrate that CaV1.2 is indeed involved in the effects of 5G technology on sleep, the researchers are investigating in this study, with healthy subjects carrying the sought-after genetic variant, whether the administration of nimodipine and thus the blockade of the calcium channel before exposure mitigates or eliminates the effects of EMF on sleep health.

Detailed Description

This study tests a causal role of voltage-gated CaV1.2 calcium channels in mediating the effects of a 5G electromagnetic field on sleep-related brain health in humans.

The study comprises a large-scale genetic screening in order to select the allele-carriers, a sleep screening night, and four experimental nights where participants are exposed to either an active 5G field or sham, combined with either nimodipine (which is a brain-penetrant L-type calcium channel blocker) or placebo. Participants will undergo polysomnographic recordings, high-density electroencephalography (EEG) during wake, peripheral measurements, cognitive and neuropsychiatric assessments.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
30
Inclusion Criteria

For the first part of the study (genotyping and questionnaires):

  • Age: 20-40 years old.
  • German and/or English language skills (reading and writing)
  • Informed Consent as documented by signature

For the second and third party of the study:

  • Completion of the first part of the present study or of the precursor study (BASEC-ID: 2016-02049)

  • CACNA1C rs7304986 T/C allele-carrier

  • Male gender

  • Female gender if using hormonal contraception for the duration of the study (e.g., pill as combination/single preparation, three-month injection, hormonal IUD, hormonal implant, hormonal patch)

  • Right-handedness

  • Body Mass Index (BMI): BMI comprised between 17.0 kg/m2 and 26.0 kg/m2

    • Moderate alcohol consumption (less than 5 reported alcoholic drinks per week)
    • Moderate caffeine consumption (less than 3 reported caffeinated beverage or food products per day such as cola, coffee, energy drinks, green and black tea, chocolate)
    • Informed Consent as documented by signature.
Exclusion Criteria

For the second and third party of the study:

  • Travel with a time difference of more than 2 time zones in the last 30 days before study entry or during the study period
  • Shift work at night
  • Extreme chronotype or duration of sleep (5 hours < reported habitual sleep duration per night > 10 hours)
  • Known sleep disorders or diseases
  • Serious acute or chronic neurological, mental, or general medical conditions that, in the opinion of the investigator, may pose a risk to participation or affect study measurements
  • Use of medications (regularly or during the study period) that, in the opinion of the investigator, may affect study measurements.
  • Use of illegal drugs
  • Smoking (or other tobacco use)
  • Known or suspected non-compliance with the investigators' indications
  • Inability to follow the procedures of the study, e.g., due to language problems, psychological disorders, dementia, etc.
  • Severe skin allergies or hypersensitivities
  • Participation in another clinical trial in the last 30 days prior to inclusion or during the present study
  • Contraindications to nimodipine, e.g., known hypersensitivity or allergy to nimodipine or any of the excipients
  • Other cases in which the use of nimodipine is discouraged according to the summary of product characteristics (SPC)
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study
  • Lack of safe contraception, defined as: female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Note: Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of child bearing potential)
  • Sleep apnea and nocturnal myoclonus index of ≥ 5 per hour of sleep (as assessed during the screening night)
  • Sleep efficiency < 80% (as assessed during the screening night)
  • Other relevant findings in the screening/adaptation night (e.g., indications of sleep disorders), which in the opinion of the investigator may pose a risk for participation or influence the study measurements.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Arm35G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm4Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm45G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm6Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm65G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm7Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm95G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm10Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm105G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm11Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm115G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm12Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm75G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm8Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm85G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm9Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm135G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm14Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm145G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm15Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm155G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm16Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm165G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm17Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm175G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm18Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm185G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm19Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm195G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm20Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm205G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm21Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm215G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm22Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm225G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm23Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm125G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm5Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm55G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm13Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm235G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm24Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm245G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm2Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm25G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Arm1Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining eighteen sequences will be assigned to one participant each.
Arm15G RF-EMFThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining eighteen sequences will be assigned to one participant each.
Arm3Nimodipine CapsulesThe study includes 24 arms, each corresponding to one of the 24 unique sequences in which the four intervention combinations (drug/placebo × active/sham) can be administered. Given that the expected total sample size is 30 participants, six of these sequences will be randomly assigned to two participants, while the remaining 18 sequences will be assigned to one participant each.
Primary Outcome Measures
NameTimeMethod
Sleep spindle center frequencyAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

In previous research, the investigators detected a positive shift in the sleep spindle center frequency (during NREM sleep phase) after 30-min pre-sleep exposure to a 5G signal at 3600 MHz, 100 MHz bandwidth in heterozygous T/C allele-carriers (rs7304986) compared to sham.

The sleep spindle center frequency is a parameter that can be extracted from the overnight electroencephalographic recordings.

Secondary Outcome Measures
NameTimeMethod
Mental suggestibility tendencyAt the large-scale genetic screening

Participants report about their mental suggestibility tendency during the large-scale genetic screening (first study part) via filling out the online questionnaire "Short Suggestibility Scale".

Sex distribution of participantsAt the large-scale genetic screening

Self-reported biological sex (male or female) is recorded during the large-scale genetic screening (first study part) via an online questionnaire.

Age of ParticipantsAt the large-scale genetic screening

Age is recorded in years based on the year of birth provided during the large-scale genetic screening (first study part) via an online questionnaire.

EEG power spectra during Non-Rapid-Eye-Movement (NREM) sleepAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Power spectra will be computed from artifact-free EEG data recorded during NREM sleep. Spectral power (µV²/Hz) will be computed in standard frequency bands.

Total sleep timeAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Sleep electroencephalographic data allow to extract total sleep time (min) (total amount of time spent asleep)

Neurocognitive performance as assessed in the psychomotor vigilance task (PVT)Assessed on each of the four experimental nights, pre- and post-sleep

The PVT is administered before and after sleep at each experimental night and provides a score reflecting sustained or vigilant attention performance.

Heart rateAssessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings

Heart rate (bpm) is extracted from electrocardiographic recording during exposure and from polysomnographic overnight recordings

Handedness of participantsAt the large-scale genetic screening

Participants report their handedness (right-handed or left-handed) during the large-scale genetic screening (first study part) via an online questionnaire.

BMI of participantsAt the large-scale genetic screening

Self-reported height (in centimeters) and weight (in kilograms) of participants is reported during the large-scale genetic screening (first study part) via an online questionnaire. From Height and Weight, BMI is calculated.

Highest level of education of participantsAt the large-scale genetic screening

The highest level of education of participants (elementary school, professional school, high school, university of applied sciences and arts, or university) is self-reported during the large-scale genetic screening (first study part) via an online questionnaire.

Phone call timeAt the large-scale genetic screening

Participants report their phone call time without headphones (Not at all, Less than 1 hour per week, 1-2 hours per week or more than 2 hours per week) during the large-scale genetic screening (first study part) via an online questionnaire.

Caffeine consumptionAt the large-scale genetic screening

Participants report their caffeine consumption (None, 1-2 caffeinated foods or beverages per day, 3-5 caffeinated foods or beverages per day or More than 5 caffeinated foods or beverages per day) during the large-scale genetic screening (first study part) via an online questionnaire.

Alcohol consumptionAt the large-scale genetic screening

Participants report their alcohol consumption (None, Less than 1 glass per week, 1-2 glasses per week, 3-5 glasses per week or More than 5 glasses per week) during the large-scale genetic screening (first study part) via an online questionnaire.

Electrohypersensitivity (EHS) statusAt the large-scale genetic screening

Participants report their EHS status during the large-scale genetic screening (first study part) via filling out the online questionnaire by M. Röösli, E. Mohler, and P. Frei (2010).

Sleep disturbancesAt the large-scale genetic screening

The presence of sleep disturbances is self-reported by participants during the large-scale genetic screening (first study part) via an online questionnaire.

ComorbiditiesAt the large-scale genetic screening

Participants self-report the presence of comorbidities during the large-scale genetic screening (first study part) via an online questionnaire.

Night-shift workAt the large-scale genetic screening

Participants report if they engage in night shift work during the large-scale genetic screening (first study part) via an online questionnaire.

Use of medicationsAt the large-scale genetic screening

Self-reported use of medication is recorded during the large-scale genetic screening (first study part) via an online questionnaire.

Use of illegal drugsAt the large-scale genetic screening

Self-reported use of illegal drugs is recorded during the large-scale genetic screening (first study part) via an online questionnaire.

Use of tobacco productsAt the large-scale genetic screening

Use of tobacco products is reported during the large-scale genetic screening (first study part) via an online questionnaire.

Subjective sleep qualityAt the large-scale genetic screening

Participants report about their subjective sleep quality during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index" (high global PSQI score indicates poor sleep quality).

Daytime sleepinessAt the large-scale genetic screening

Participants report about their daytime sleepiness during the large-scale genetic screening (first study part) via filling out the online questionnaire "Epworth Sleepiness Scale " (high ESS score indicates high daytime sleepiness).

Depressive tendencyAt the large-scale genetic screening

Participants report about their depressive-like symptoms (experienced in the last 2 weeks) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Beck Depression Index II (BDI-II)".

Diurnal preferenceAt the large-scale genetic screening

Participants report about their diurnal preference during the large-scale genetic screening (first study part) via filling out the online questionnaire "Munich Chronotype Questionnaire" (if the mid-sleep time on the MCTQ is earlier than 04:00, the participant is considered as preferential morning type, otherwise as preferential evening type).

Habitual bedtimeAt the large-scale genetic screening

Participants report about their subjective habitual bedtime (hh:mm) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

Habitual rise timeAt the large-scale genetic screening

Participants report about their subjective habitual rise time (hh:mm) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

Reported time to fall asleepAt the large-scale genetic screening

Participants report about their subjective time to fall asleep (min) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

Reported sleep durationAt the large-scale genetic screening

Participants report about their subjective sleep duration (h:mm) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Pittsburgh Sleep Quality Index".

Positive and Negative Affect ScheduleAt the large-scale genetic screening

Participants report about positive and negative feelings (over the last 12 months) during the large-scale genetic screening (first study part) via filling out the online questionnaire "Positive and Negative Affect Schedule".

Nocturnal mentationAt the large-scale genetic screening

Participants report about their nocturnal mentation during the large-scale genetic screening (first study part) via filling out online the "Dream Thought Questionnaire".

Schizotypal tendencyAt the large-scale genetic screening

Participants report about their schizotypal tendencies during the large-scale genetic screening (first study part) via filling out an online adaptation of the questionnaire "Magical Ideation Scale (MIS)".

ADHD tendencyAt the large-scale genetic screening

Participants report about their ADHD-like symptoms during the large-scale genetic screening (first study part) via filling out the online questionnaire "Adult ADHD Self-Report Scale v1.1 (ASRS)".

EEG power spectra during wakefulnessAssessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings

Power spectra will be computed from artifact-free EEG data recorded during wakefulness. Spectral power (µV²/Hz) will be computed in standard frequency bands.

EEG power spectra during Rapid Eye Movement (REM) sleepAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Power spectra will be computed from artifact-free EEG data recorded during REM sleep. Spectral power (µV²/Hz) will be computed in standard frequency bands.

Aperiodic component of the EEG power spectrum during NREM sleepAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

The NREM sleep power spectra will be used to extract and parametrize the aperiodic component.

Aperiodic component of the EEG power spectrum during REM sleepAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

The REM sleep power spectra will be used to extract and parametrize the aperiodic component.

Aperiodic component of the EEG power spectrum during wakefulnessAssessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings

The wake power spectra will be used to extract and parametrize the aperiodic component.

Periodic component of the EEG power spectrum during NREM sleepAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Gaussian peaks detected in the NREM sleep power spectrum will be used to extract the periodic components, including center frequency, power, and bandwidth.

Periodic component of the EEG power spectrum during REM sleepAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions.

Gaussian peaks detected in the REM sleep power spectrum will be used to extract the periodic components, including center frequency, power, and bandwidth.

Periodic component of the EEG power spectrum during wakefulnessAssessed on each of the four experimental nights, from pre- and post-sleep wake electroencephalographic recordings

Gaussian peaks detected in the wake power spectrum will be used to extract the periodic components, including center frequency, power, and bandwidth.

Sleep efficiencyAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Sleep electroencephalographic data allow to extract sleep efficiency (%) ((total sleep time/time in bed) \* 100)

Sleep latencyAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions.

Sleep electroencephalographic data allow to extract sleep latency (time between lights-off and first occurrence of NREM sleep stage N2).

Wakefulness after sleep onsetAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Sleep electroencephalographic data allow to extract WASO (min) (wakefulness after sleep onset).

Time spent in the different sleep stagesAssessed on each of the four experimental nights, from overnight electroencephalographic recordings following randomized combinations of drug (nimodipine or placebo) and RF-EMF exposure (5G or sham), with a minimum of 3 days washout between sessions

Sleep electroencelographic data allow to calculate the time (min) spent in each sleep substage (NREM1, NREM2, NREM3, REM).

Neurocognitive performance as assessed in the sequential finger tapping task (FTT)Assessed on each of the four experimental nights, pre- and post-sleep

The FTT is administered before and after sleep at each experimental night and provides a score reflecting procedural memory and learning performance.

Neurocognitive performance as assessed in the visuospatial 2D Object Location Task (OLT)Assessed on each of the four experimental nights, pre- and post-sleep

The OLT is administered before and after sleep at each experimental night and provides a score reflecting declarative memory and learning performance.

Heart rate variabilityAssessed on each of the four experimental nights, from electrocardiographic recordings during pre-sleep exposure and polysomnographic overnight recordings

Heart rate variability is extracted from electrocardiographic recording during exposure and from polysomnographic overnight recordings.

Pregnancy statusAt the large-scale genetic screening

Female participants report current pregnancy status during the large-scale genetic screening (first study part) via an online questionnaire.

Pupil sizeAssessed on each of the four experimental nights, from pupillometry recordings during pre-sleep exposure.

Pupil size variation is recorded during exposure.

Trial Locations

Locations (1)

University of Zurich, Institute of Pharmacology and Toxicology

🇨🇭

Zurich, Switzerland

University of Zurich, Institute of Pharmacology and Toxicology
🇨🇭Zurich, Switzerland
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