Clinical trial NCT06100185: Wearable tES for Insomnia
Official title: Wearable Neurotechnology for Treatment of Insomnia (tES)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia
Keywords: tES
Insomnia
Sleep
Lead sponsor: Uniformed Services University of the Health Sciences
Sponsor class: FED
First posted: 2023-10-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Sleep Onset Latency Change from Baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: ISI Change from Baseline
timeFrame: 8 weeks
measure: PHQ-9 Change from Baseline
timeFrame: 8 weeks
measure: STAI Change from Baseline
timeFrame: 8 weeks
measure: Total Sleep Time
timeFrame: Baseline
measure: Total Sleep Time Change from Baseline
timeFrame: 8 weeks
measure: EEG spectral changes from baseline (Delta power increase)
timeFrame: 8 weeks
measure: Heart rate variability change from baseline
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: John K Werner, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: