Wearable Transcranial Electrical Stimulation (tES) for Insomnia

NCT06100185 | Active Not Recruiting DMC FDA Device

• 1 other identifier: WNTI-2022
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

tES; Insomnia; Sleep

Outcome Measures

Primary Outcomes (1)

• 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).

  5 weeks

Secondary Outcomes (5)

• ISI Change from Baseline

  5 weeks

• PHQ-9 Change from Baseline

  5 weeks

• Total Sleep Time Change from Baseline

  5 weeks

• EEG spectral changes from baseline (Delta power increase)

  5 weeks

• Heart rate variability change from baseline

  5 weeks

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Device: PeakSleep

Sham Arm

SHAM COMPARATOR

Device: Sham

Interventions

PeakSleep 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).

Experimental Arm

Sham 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.

Sham Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with sleep onset insomnia
• Self report insomnia diagnosis (ISI score ≥15)
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• John K Werner, MD PhD

  Uniformed Services University of the Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: October 25, 2023
• Study Start: October 25, 2023
• Primary Completion: January 29, 2025
• Study Completion (Estimated): June 7, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The de-identified individual participant data (IPD) and supporting information will be available starting 120 days after study completion, following destruction of the spreadsheet linking participant identities to study codes. The data will be maintained indefinitely by Dr. Werner for future research use, with no specified end date.
• Access Criteria: Only research staff listed in the study protocol and approved by the IRB will have access to the IPD and supporting information. They will be able to access de-identified EEG data and sleep diary responses linked only to alphanumeric codes. Access will be through secure, password-protected computers or servers. After de-identification, the data may be shared for future research with qualified investigators upon request and IRB approval, but will remain free of any personal identifiers and only include data necessary for approved analyses.

Locations

US (1)