Back to search results

INSIGHT: Smartwatch for Sleep Issues in Military Service Members

The INSIGHT study is looking at how sleep problems, nightmares, and an overactive nervous system (sympathetic hyperactivity) affect current and former military service members. These issues are common in those with traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD). This study will test a NightWare smartwatch, which detects signs of an overactive nervous system during sleep, like heart rate spikes. Some participants will receive a working smartwatch, while others will receive a non-working (sham) device. The main goal is to see if the NightWare smartwatch improves sleep quality within 30 days. You may be able to join if you are 18-62 years old, a current or former military service member, and have a habitual bedtime between 9 PM and 1 AM. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 180 participants. Participants will be assigned to either receive a working NightWare smartwatch or a sham (non-working) device.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 30 days to measure sleep quality improvement and autonomic predictors of treatment response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07288593

INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention

Not Yet Recruiting
NAAges 18–62InterventionalTreatment
Uniformed Services University of the Health Sciences
~180 participants
Updated 2026-04-28 on ClinicalTrials.gov
What's tested:NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns.Sham (No Treatment)

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
NW efficacy towards sleep quality improvement
Measured over 30 days
+1 more outcome measured

Conditions

Nightmare
Insomnia
PTSD
TBI
Sleep Disorder (Disorder)
REM Behavior Disorder

Explore related trials

InsomniaNightmarePost-Traumatic Stress DisorderREM sleep behavior disorderTraumatic Encephalopathy

Where it's being run

2 sites across 2 states
Maryland1
Minnesota1

Who to contact

Kent Werner, MD/PhD
[email protected]
3012953840
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Defense Enrollment Eligibility Reporting System (DEERS) Eligible
Current or former military service member
Able to read and understand English language without the use of an interpreter
Habitual bedtime between 9:00 PM and 1:00 AM
Aged 18-62 (inclusive)
Able to commit to study procedures

Exclusion

Use of alpha or beta-receptor active medications or prescribed sleep aids in the last 3 months
Started use of SNRIs or SSRIs in the last 3 months
Pregnant
Receiving ongoing and extensive treatment for a new or acute psychiatric disorder within 90 days, other than routine follow-up and care
Starting concurrent evidence based psychiatric treatment within the past three months
Diagnosis of a serious medical condition (i.e., late-stage cancer or heart disease)
Routine night shift work in the past 3 months
Unstable neurological disease/autonomic disorders/ heart conditions/psych/ sleep or other unstable disorder as determined by the Principal Investigator/Associate
Investigators determined by clinical interview by Mini international neuropsychiatric interview and medical health questionnaire
Excessive alcohol use as determined by the AUDIT-C (AUDIT-C \> 3)
Started using any other medication (prescribed or over-the-counter) for the purpose of improving sleep in the last 90 days (e.g., barbiturates, benzodiazepines, melatonin, natural supplements and herbs, antidepressants, antihistamines, etc.)
Receiving treatment for substance use disorder within 90 days from the start of the study
Evidence of moderate or severe Obstructive Sleep Apnea (OSA): Determined by the STOP-BANG questionnaire: STOP-BANG greater than 5 Determined by EMR PSG records: moderate or severe OSA \[apnea-hypopnea index (AHI)≥15\]
Clinically significant suicidality as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Currently participating in other research studies for improving sleep
Currently participating in other research studies for improving PTSD
Currently in therapy for the primary purpose of improving sleep (e.g., CBT-I)
Currently undergoing other treatment to improve sleep (e.g., acupuncture)
History or diagnosis of any of the following sleep disorders: narcolepsy, shift-work disorder or circadian rhythm disorders
Prone to problems with venipuncture including fainting, hematoma, and infection
Moderate and high nicotine dependence based on the Fagerstrom Test for Nicotine Dependence (\> 4 on the Fagerstrom Test for Nicotine Dependence) High caffeine dependence based on the Caffeine Dependence Questionnaire (\> 30 on the Caffeine Dependence Questionnaire)
Currently experiencing a neurological disorder (e.g., stroke, Parkinson's, MS, etc.)
Exclusion for optional MRI visit:

What this trial measures

  • NW efficacy towards sleep quality improvement30 days

    Compare Pittsburgh Sleep Quality Index (PSQI) pre- and post-intervention

  • Autonomic predictors of response to treatment30 days

    Predict response to therapy using a model of baseline sympathetic measurements, a "Multi-organ Autonomic Index of Sleep"(MAIS). This model will predict sleep quality using a composite measure of heart rate variability, electrodermal activity, k-complex EEG occurences, estimated locus coruleus activity, and urine noradrenaline.