InsomniaNCT06100185
Wearable Transcranial Electrical Stimulation (tES) for Insomnia
A study testing PeakSleep in people with Insomnia, run by Uniformed Services University of the Health Sciences at 1 site in United States.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Insomnia
- What is being tested?
- PeakSleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2023to 7 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20814
About this study
Official title: Wearable Neurotechnology for Treatment of Insomnia (tES)
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- PeakSleep, Sham
- Keywords
- tES, Insomnia, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PeakSleepDevice
The PeakSleepTM is a constant current device which delivers stable stimulation as a function of the impedance measured across the electrodes (e.g. it varies voltage to produce a steady current). The device gradually ramps up the current as the impedance decreases during the stimulation session. The device uses stimulation amplitudes in the range of 100uA to 500uA at each electrode pair. Devices will be configured to deliver 100 stimulation trains over 30 minutes where each train is 6 pulses of 0.75Hz trapezoidal stimulation (each train lasts 8 seconds). The inter-train interval is 10 seconds leading to a total stimulation time of <14 minutes with a maximum dose of 1mA (500uA per electrode pair).
ShamDevice
Sham is delivered with the same devices which are alternatively configured to deliver a trivially low amplitude (e.g. 100uA) waveform of a different frequency (e.g. 25 Hz) for the same treatment duration. Beyond differences in amplitude and frequency of stimulation, devices will be operated in exactly the same way during sham treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Not described Receives: Device: PeakSleep |
| Sham Arm | Sham comparator | Not described Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Onset Latency Change from Baseline
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).
Measured: 5 weeks
Secondary outcomes (5)
ISI Change from Baseline
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.
Measured: 5 weeks
PHQ-9 Change from Baseline
The Patient Health Questionnaire (PHQ-9, score from 0-27, higher is worse depression) will assess psychiatric conditions at visits 1, 3, and 5.
Measured: 5 weeks
Total Sleep Time Change from Baseline
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.
Measured: 5 weeks
EEG spectral changes from baseline (Delta power increase)
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).
Measured: 5 weeks
Heart rate variability change from baseline
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)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start25 Oct 2023
- Primary completion29 Jan 2025
- Study completion7 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uniformed Services University of the Health Sciences
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John K Werner, MD PhD, Principal investigator, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100185
- Sponsor's protocol ID
- WNTI-2022
- Status last verified
- Mar 2026
- First submitted
- 28 Jul 2023
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The specific individual participant data (IPD) to be shared includes de-identified EEG recordings collected during treatment sessions and responses to sleep diary questions. This data is coded using an alphanumeric identifier unlinked from any personal information. The mapping spreadsheet linking identifiers to participants will be destroyed 120 days after study completion, fully de-identifying the data. Participants consent to future use of their data through an opt-in checkbox and may withdraw consent at any time. Only approved research staff will access the data, stored securely per DoD and USUHS guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Neurotechnology for Treatment of Insomnia (tES)
- ClinicalTrials.gov ID
- NCT06100185
- Acronym / sponsor ID
- WNTI-2022
- Conditions
- Insomnia
- Keywords
- tES, Insomnia, Sleep
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Uniformed Services University of the Health SciencesUS federal agency
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 7 Jun 2026 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Device: PeakSleep |
| Sham Arm | Sham comparator | Device: Sham |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PeakSleepThe PeakSleepTM is a constant current device which delivers stable stimulation as a function of the impedance measured across the electrodes (e.g. it varies voltage to produce a steady current). The device gradually ramps up the current as the impedance decreases during the stimulation session. The device uses stimulation amplitudes in the range of 100uA to 500uA at each electrode pair. Devices will be configured to deliver 100 stimulation trains over 30 minutes where each train is 6 pulses of 0.75Hz trapezoidal stimulation (each train lasts 8 seconds). The inter-train interval is 10 seconds leading to a total stimulation time of <14 minutes with a maximum dose of 1mA (500uA per electrode pair). | Device | Experimental Arm |
| ShamSham is delivered with the same devices which are alternatively configured to deliver a trivially low amplitude (e.g. 100uA) waveform of a different frequency (e.g. 25 Hz) for the same treatment duration. Beyond differences in amplitude and frequency of stimulation, devices will be operated in exactly the same way during sham treatment. | Device | Sham Arm |
Primary outcome
Sleep Onset Latency Change from Baseline
Time frame: 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).
5 secondary outcomes
ISI Change from Baseline
Time frame: 5 weeks
PHQ-9 Change from Baseline
Time frame: 5 weeks
Total Sleep Time Change from Baseline
Time frame: 5 weeks
EEG spectral changes from baseline (Delta power increase)
Time frame: 5 weeks
Heart rate variability change from baseline
Time frame: 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2026.
- Individual participant dataSharing planned: Yes. The specific individual participant data (IPD) to be shared includes de-identified EEG recordings collected during treatment sessions and responses to sleep diary questions. This data is coded using an alphanumeric identifier unlinked from any personal information. The mapping spreadsheet linking identifiers to participants will be destroyed 120 days after study completion, fully de-identifying the data. Participants consent to future use of their data through an opt-in checkbox and may withdraw consent at any time. Only approved research staff will access the data, stored securely per DoD and USUHS guidelines.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John K Werner, MD PhD principal investigator
Uniformed Services University of the Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PeakSleep in people with Insomnia, run by Uniformed Services University of the Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Onset Latency Change from Baseline (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.