RECRUITING

Wearable tES for Insomnia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Wearable Neurotechnology for Treatment of Insomnia (tES)

Quick Facts

Study Start:2023-10-25

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06100185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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\	* 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.

Inclusion Criteria

Exclusion 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\*

* 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.

Contacts and Locations

Study Contact

Adriana Penafiel, BA

CONTACT

(240) 630-1951

adriana.penafiel.ctr@usuhs.edu

Sonja T Skeete, BS

CONTACT

(301) 319-4599

sonja.t.skeete.ctr@health.mil

Principal Investigator

John K Werner, MD PhD

PRINCIPAL_INVESTIGATOR

Uniformed Services University of the Health Sciences

Study Locations (Sites)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814

United States

Collaborators and Investigators

Sponsor: Uniformed Services University of the Health Sciences

John K Werner, MD PhD, PRINCIPAL_INVESTIGATOR, Uniformed Services University of the Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25

Study Completion Date2025-09

Study Record Updates

Study Start Date2023-10-25

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

tES
Insomnia
Sleep

Additional Relevant MeSH Terms

Insomnia