INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-62
SponsorUniformed Services University of the Health Sciences

About this trial

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-based sensors, accelerometry rings, blood pressure devices, temperature sensors, and smartwatches, to capture autonomic activity, sleep architecture, cardiovascular and respiratory variability, movement, sudomotor activity, and circadian body temperature patterns. Ecological momentary assessments administered three times daily track fluctuations in sleep quality, mood, PTSD symptoms, and daytime functioning, while urine samples collected on the final three days allow for biochemical analysis of hormonal and sympathetic biomarkers. After the at-home period, all participants complete an overnight in-lab polysomnogram combined with fNIRS to measure sleep stages, autonomic dynamics, cerebral hemodynamics, and glymphatic signatures. A subset of participants also completes an optional overnight MRI with simultaneous EEG following controlled sleep deprivation, enabling state-of-the-art imaging of human glymphatic activity using the MAGNUS MRI platform. This optional visit provides unprecedented insight into how TBI, PTSD, and insomnia alter the physiology of sleep-dependent brain fluid dynamics. In Phase 2, all poor sleepers enter a double-blind, sham-controlled, 30-day randomized trial testing the therapeutic potential of the NightWare smartwatch. NightWare detects sympathetic surges during sleep through heart rate elevations and movement patterns and delivers brief haptic vibrations aimed at interrupting escalating autonomic arousal. Although originally cleared for nightmare treatment, its mechanism is well suited for SNH-related insomnia more broadly. Participants use the device daily while continuing EMA surveys, wearable monitoring, and cognitive assessments, generating rich physiological and behavioral data throughout the intervention. The primary goal is to determine whether reducing nocturnal sympathetic spikes leads to measurable improvements in sleep quality, autonomic stability, daytime functioning, and symptom burden. In parallel, Phase 2 data enable development of the Multi-Organ Autonomic Index of Sleep, an integrated biomarker model that combines neurological, cardiovascular, respiratory, and dermal signals to predict treatment response and classify insomnia subtypes.

The INSIGHT study will produce the most comprehensive dataset to date linking autonomic physiology, glymphatic function, sleep architecture, wearable-derived biomarkers, cognition, and clinical outcomes in warfighters. By identifying physiological signatures of sympathetic hyperarousal and determining whether a non-pharmacological wearable intervention can meaningfully improve sleep, INSIGHT directly supports Department of Defense priorities to enhance readiness, resilience, and long-term neurological health in service members. Wearable tools capable of monitoring and improving sleep outside the laboratory have the potential to transform both clinical care and operational performance, offering scalable and accessible approaches to restoring sleep and optimizing recovery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns.

    Device

    Participants assigned to the active intervention receive a functioning NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns. When these stress signals exceed a preset threshold, the device delivers brief, gentle haptic vibrations designed to interrupt escalating autonomic arousal without fully awakening the user. The goal is to reduce nighttime sympathetic hyperactivity, improve sleep continuity, and alleviate insomnia symptoms. Participants wear the device nightly for 30 days and complete daily surveys and physiological monitoring to assess treatment effects.

  • Sham (No Treatment)

    Device

    NW device that does not deliver any intervention

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Control ArmSham comparator 1 intervention
Group B: Intervention ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

NW efficacy towards sleep quality improvement

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

Time frame
30 days
2

Autonomic predictors of response to treatment

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.

Time frame
30 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Uniformed Services University of the Health Sciences

Lead sponsor

University of Minnesota

Collaborator

Walter Reed National Military Medical Center

Collaborator

Henry M. Jackson Foundation for the Advancement of Military Medicine

Collaborator

The Geneva Foundation

Collaborator

Applied Physics Laboratory

Collaborator

National Intrepid Center of Excellence

Collaborator

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