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NCT07288593 · ClinicalTrials.gov registry record · NA
INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention
A NA study, sponsored by Uniformed Services University of the Health Sciences.
- Not yet
- Registry status
- NA
- Development phase
- 180
- Enrollment target
NCT07288593: Clinical Trial NA study, sponsored by Uniformed Services University of the Health Sciences.
NCT07288593 is a NA study that has not yet begun recruiting, run by Uniformed Services University of the Health Sciences. The registered enrollment target is 180 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07288593, a NA study, has not yet begun recruiting, sponsored by Uniformed Services University of the Health Sciences.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
Study Summary
The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters with a history of traumatic brain injury, post-traumatic stress disorder, or chronic operational stress commonly report disrupted sleep accompanied by manifestations of nocturnal sympathetic activation such as diaphoresis, palpitations, hyperarousal, and nightmares. These symptoms erode sleep quality, reduce cognitive performance, and undermine psychological resilience and operational readiness. Insomnia is two to three times more common in military populations than in civilians, and both TBI and PTSD independently elevate the risk for dysregulated autonomic tone. Excessive sympathetic activity during REM sleep disrupts the normally quiescent locus coeruleus state required for adaptive emotional processing and may contribute to the genesis of nightmares. Excessive sympathetic tone may also interfere with deep NREM-dependent glymphatic clearance, a recently discovered mechanism that supports cognitive restoration and metabolic waste removal. Yet, no study has comprehensively linked these physiological processes in warfighters or evaluated whether wearable-derived autonomic measures can meaningfully stratify insomnia phenotypes. The INSIGHT protocol addresses this gap through a two-phase design integrating multimodal biomarker collection, wearable technology validation, advanced imaging, and a randomized controlled intervention. Phase 1 enrolls 250 participants (50 healthy controls and 200 poor sleepers with or without PTSD and TBI) who undergo structured screening, cognitive testing, and detailed baseline assessments before completing a 2-week at-home data collection period. During this period, participants wear a suite of devices, including EEG headbands, ECG patches, PPG
Primary Outcome
Compare Pittsburgh Sleep Quality Index (PSQI) pre- and post-intervention
Interventions
- DEVICE Sham (No Treatment)
- DEVICE NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2026-06-01 |
| Est. Completion | 2027-12 |
| Phase | NA |
What is known before NCT07288593 opens enrollment
NCT07288593 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham (No Treatment) is the first listed.
NCT07288593 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07288593 about?
NCT07288593 is a clinical study titled "INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention". The INSIGHT study is a multi-site clinical research program designed to examine how insomnia and symptoms of sympathetic hyperactivity impair sleep, cognition, and physiological restoration in warfighters, and to evaluate whether a wearable therapeutic device can improve these outcomes. Warfighters ...
What is the current status of trial NCT07288593?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2026-06-01. Estimated completion is 2027-12.
What interventions are being tested in trial NCT07288593?
The interventions under investigation include: Sham (No Treatment) (DEVICE), NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns. (DEVICE).
Who is sponsoring clinical trial NCT07288593?
This trial is sponsored by Uniformed Services University of the Health Sciences, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07288593's enrollment target sits among peer trials
180 586th of 2000 higher than 1,397 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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