Enhancement of Sleep With Wearables
- Conditions
- Sleep
- Interventions
- Device: Application of tonesDevice: No application of tones
- Registration Number
- NCT03420677
- Lead Sponsor
- Swiss Federal Institute of Technology
- Brief Summary
Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Informed Consent as documented by signature
- For women: Hormonal contraception, if menstrual cycle is still present or has been present less than a year ago
- Good general health status
- Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study
- Male and Female subjects 18-35 years of age or 60-84 years of age
- German speaking
- Women who are pregnant or breast feeding,
- Known or suspected non-compliance, drug or alcohol abuse,
- Intake of sleep altering medication
- Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Presence or history of diagnosed psychiatric/neurologic disorder/lesion of the central nervous system (CNS),
- Diagnosed internal disease,
- Presence of sleep disorders,
- Shift-work (work during the night) or situations that require several awakenings during the night (e.g. newborn)
- Travelling more than 2 time zones in the last month before intervention starts or during intervention (study start will be shifted accordingly)
- Hearing disability/ hearing aid
- Skin disorders/problems in face region that will worsen with /not allow adhesive electrode application
- Nicotine/Cannabis use
- High caffeine consumption (> 5 servings/day; including coffee, energy drink)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Application of tones Application of tones During non-rapid eye movement (NREM) sleep short tones will be played No application of tones No application of tones During NREM sleep no short tones will be played
- Primary Outcome Measures
Name Time Method Sleep quality From baseline period to study completion, assessed up to 2 months Objective information about sleep macro- and microstructure will be assessed including measures like sleep architecture, amount of slow wave activity (SWA), amount of spindles, awakenings during sleep, and sleep fragmentation. In addition, subjective sleep quality will be obtained by questionnaires every morning over the intervention period. These measures will show whether auditory stimulation enhanced overall sleep quality compared to sham.
- Secondary Outcome Measures
Name Time Method Daily functioning - Mood From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks Mood will be digitally assessed using a daily mood scale over the intervention period
Daily functioning - Vigilance From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period
Physiological parameters - Physical activity Through study completion, approximately 2 months Physical activity levels will be obtained using wearable monitors
Daily functioning - Quality of life From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period
Daily functioning - Cognition From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks Cognition will be assessed using a digital test battery before and after each intervention
Physiological parameters - Cardiovascular From baseline period to study completion, assessed up to 2 months R-R interval based assessments will be obtained using wearable monitors
Trial Locations
- Locations (1)
Swiss Federal Institute of Technology
🇨🇭Zürich, Zurich, Switzerland