Wearable Transcranial Electrical Stimulation (tES) for Insomnia

NCT ID: NCT06100185

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-25
• Study Completion Date: 2026-01-31

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.

Conditions

Insomnia

Keywords

tES; Insomnia; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental Arm

Group Type: EXPERIMENTAL

PeakSleep

Intervention Type: DEVICE

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).

Sham Arm

Group Type: SHAM_COMPARATOR

Sham

Intervention Type: DEVICE

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.

Interventions

PeakSleep

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).

Intervention Type: DEVICE

Sham

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uniformed Services University of the Health Sciences

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John K Werner, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Locations

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ethan Cheraghpour, BA

Role: CONTACT

Phone: (301) 461-7328

Email: ethan.cheraghpour.ctr@usuhs.edu

Heather Decot, BS

Role: CONTACT

Phone: (703) 577-6720

Email: heather.decot.ctr@usuhs.edu

Other Identifiers

WNTI-2022

Identifier Type: -

Identifier Source: org_study_id