Wearable tES for Insomnia

Not Applicable

Recruiting

• Conditions: Insomnia

• Registration Number: NCT06100185
• Lead Sponsor: Uniformed Services University of the Health Sciences

Brief Summary

The purpose of this study is to investigate the ability of a translational device, Teledyne PeakSleep, to reduce sleep onset latency, reduce time awake after sleep onset and improve restfulness and the subjective benefits of sleep in a patient population with insomnia via transcranial direct current stimulation (tDCS) applied to frontal lobe circuits.

Detailed Description

The purpose of this research study is to investigate a new, targeted intervention to improve outcomes for those suffering from insomnia by attempting to enhance the brain rhythms within the frontal lobe implicated in slow wave generation during the transition from wake to sleep. The device applies a pulsed trapezoidal direct current waveform at 0.75 Hz to the frontal areas of the brain immediately prior to attempted sleep onset to facilitate the transition to sleep.

During this cross-over trial, patients will be asked to use a PeakSleep wearable neurotechnology prototype headband, which delivers \<14 minutes of frontal tDCS over a 30-minute period, immediately before trying to fall asleep. Using an active stimulation versus sham paradigm, we will compare actigraphy data, physiological data, and subjective sleep measures against a pre-treatment baseline in the same patient.

Participants will complete five in-person visits over the course of the 8-week study. The first visit includes the collection of baseline self-reported data and actigraphy device training. All subsequent visits involve headset training, downloading PeakSleep and actigraphy data, repeating self-reported data measures, and reporting user experience with the device. Participants will not perform any formal sleep study visits and instead provide daily actigraphy data via a FitBit and EEG data when wearing PeakSleep in their own home.

Study Timeline

• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-10-20
• Study Start: 2023-10-25
• Study First Posted: 2023-10-25
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-09
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• diagnosed with sleep onset insomnia
• Self report insomnia diagnosis (ISI score ≥15)
• 18-70 years old that are Tricare eligible
• No pharmacologic or non-pharmacologic treatment for insomnia in the last 14 days, including over-the-counter medications such as diphenhydramine or cyclobenzaprine not using sedating medications (including over-the-counter) at bedtime in the last 14 days. These can include sedating antihistamines such as diphenhydramine/Benadryl, combination pills such as Tylenol or Advil PM, ZzzQuil. Psychiatric medications such as benzodiazepines (clonazepam/Klonopin, lorazepam/Ativan, diazepam/Valium, alprazolam/Xanax), anti-histamines (hydroxyzine/Atarax/Vistaril), or anti-psychotics (quetiapine/Seroquel).

Exclusion Criteria

• Neurologic conditions such as seizures or conditions that increase the risk of seizures, including concussions within the last 3 months; moderate or severe traumatic brain injury; stroke; multiple sclerosis; or cognitive impairment with or without the use of prescription medication or requirement for hospitalization.

• Any psychiatric disorder requiring weekly or more frequent clinical monitoring or medication changes in the last 4 weeks.

• History of neurodevelopmental disorder such as attention deficit hyperactivity disorder, learning disability, or developmental delay

• Any inpatient hospitalization, major surgery, or medical procedure within the past 6 months

• Hearing impairments requiring implanted or external devices worn at all times for amplification.

  **Pregnant or believes there is a chance of pregnancy

• Current substance use disorder (addiction) within the past year, not including nicotine Current use of narcotics (opioid based medications for the treatment of pain (OxyContin, Percocet, Vicodin, etc.) with or without a prescription within the last year

• Change in psychotropic (non sleep related) medications within the last 4 weeks (examples include: benzodiazepines, SSRI/SNRIs, bupropion, gabapentin).

• Consuming more than 10 alcoholic beverages per week

• Treatment for drug or alcohol use/abuse within the past 1 year

• Presence of a recently diagnosed or unstable sleep disorder, other than insomnia, with an treatment regimen less than 3 months old

• Any motor coordination deficits that interfere with use of the tES device

• Participants should not have trauma/cuts/rashes to their forehead or behind the ears that would interfere with wearing of the device or cause discomfort for the research subject

• Tattoos on the head

• Non-removable metal above the shoulders, except bridges or fillings, OR implanted devices anywhere in the body (e.g., pacemakers, defibrillators, cochlear implants, brain implants including deep brain stimulators or other implanted devices) presence of an unstable medical condition that significantly contributes to their insomnia (e.g. chronic pain, cough, GERD, sleep apnea) - or diagnosis of an above condition that no longer significantly contribute to insomnia but has not been stable on a treatment regimen for at least 3 months.

any suicidal attempts within the last 12 months.

• Any other condition that the investigator believes would prevent completion of the study or put participant at risk

• Any suicidal ideations or thoughts of self-harm (as measured by the PHQ-9, Item 9) within the last 2 weeks.

  • Note: Pregnancy Safety data for tES use in pregnant women is scarce but is reviewed in: Antal, Andrea, et al. "Low intensity transcranial electric stimulation: safety, ethical, legal regulatory and application guidelines." Clinical neurophysiology 128.9 (2017): 1774-1809. The authors cite two case studies of tES use in pregnant women with no impact or safety risk for the mother or fetus when tES was applied to the head at 2mA and 20-30 min per day. The recommendation by the authors is to verbally enquire as to the pregnancy status of the subjects and only deliver tES when the benefit outweighs risk. Here we propose to completely exclude this population if the questionnaire reveals they are pregnant or are trying to become pregnant. In the event that the patient is untruthful regarding their pregnancy status we view the risk as insignificant given these reported studies and the fact that our dose is <¼ the dose used in them. For this reason we have chosen not to perform a urine test to screen for pregnancy as we view it as an obtrusive and unnecessary step given the risk profile.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Sleep Onset Latency Change from Baseline	5 weeks	FitBit actigraphy data will be collected to measure daily sleep onset latency (SOL) for two weeks at baseline (weeks 1-2, averaged) and compared to that of the study period (weeks 3-5).

Secondary Outcome Measures

Name	Time	Method
ISI Change from Baseline	5 weeks	The Insomnia Severity Index (score from 0-28, higher is worse insomnia) will capture sleep habits and insomnia symptomatology during experimental sessions. Compared across pre-screen and 5 visit blocks.
PHQ-9 Change from Baseline	5 weeks	The Patient Health Questionnaire (PHQ-9, score from 0-27, higher is worse depression) will assess psychiatric conditions at visits 1, 3, and 5.
Total Sleep Time Change from Baseline	5 weeks	FitBit actigraphy data will be collected to measure total sleep time (TST) and time awake after sleep onset (WASO) during the first treatment block, for two weeks. During weeks 3-5.
EEG spectral changes from baseline (Delta power increase)	5 weeks	The PeakSleep device contains 3 EEG sensors (approximately Fp1, Fpz, Fp2) which will collect EEG data for investigation of neural activity for both stimulation and sham conditions. Will occur nightly for two weeks during Treatment 1 (i.e., weeks 3-4).
Heart rate variability change from baseline	5 weeks	For two weeks during treatment 1, heart rate will be collected daily via FitBit. Averages will be averages compared across treatment blocks (baseline, treatment 1, washout, treatment 2)

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States