Wearable device to improve sleep for insomnia patients

Wearable Neurotechnology for Treatment of Insomnia (tES)

This study is testing a new wearable device that uses gentle brain stimulation to see if it can help people with insomnia fall asleep faster and sleep better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Uniformed Services University of the Health Sciences (Federal)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06100185 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of the Teledyne PeakSleep device, which uses transcranial direct current stimulation (tDCS) to enhance brain activity in the frontal lobe, aimed at improving sleep onset and overall sleep quality in individuals with insomnia. Participants will wear the device for less than 14 minutes before attempting to sleep, and the study will compare the effects of active stimulation against a sham treatment. Over an 8-week period, participants will attend five in-person visits to provide baseline data, receive training, and report their sleep experiences using actigraphy and EEG data collected at home.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 diagnosed with sleep onset insomnia who are Tricare eligible and have not been treated with pharmacotherapy for at least two weeks.

Not a fit: Patients with neurological disorders, unstable psychiatric conditions, or a history of neurodevelopmental disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve sleep quality and reduce insomnia symptoms for patients.

How similar studies have performed: While the use of tDCS for sleep improvement is a relatively novel approach, preliminary studies have shown promise in similar interventions.

Eligibility criteria

Inclusion Criteria:

* Diagnosed with sleep onset insomnia
* Self report insomnia diagnosis (ISI score ≥15)
* 18-70 years old that are Tricare eligible
* untreated for insomnia with pharmacotherapy (if treated; they must stop treatment for at least 2 weeks prior to enrollment) \*treatment with nonpharmacotherapy (e.g. CBT) is allowable as long as the patient still meets other criteria for inclusion and the treatment was discontinued \>14 days prior to starting the study\*

Exclusion Criteria:

* Neurological Diagnosis including epileptic seizures; recent, multiple, or severe concussion; traumatic brain injury; stroke; multiple sclerosis; or cognitive impairment with or without the use of prescription medication or requirement for hospitalization.
* Unstable psychiatric disorder requiring weekly clinical visits or medication changes within the last 4 weeks.
* History of neurodevelopmental disorder such as attention deficit hyperactivity disorder, learning disability, or developmental delay
* Recent inpatient hospitalization for surgery and/or illness, ending within the last 6 months.
* Hearing impairments requiring implanted or external devices 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
* Has sleep disorders that require treatment (e.g. CPAP for OSA), other than insomnia.
* Problems with motor coordination
* Cuts, scrapes, ingrown hairs, acne, razor burn, or scar tissue at the electrode sites.
* Tattoos on the head
* Non-removable metal anywhere in the body except bridges or fillings
* 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.

Where this trial is running

Bethesda, Maryland

• Walter Reed National Military Medical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: John K Werner, MD PhD — Uniformed Services University of the Health Sciences
• Study coordinator: Adriana Penafiel, BA

Conditions Insomnia; tES; Sleep