INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention

NCT07288593 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: USUHS.2024-136
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 2

Brief 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-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.

Conditions

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

Keywords

Nightmares; Wearables; Intervention; Sleep quality; Hyperarousal; Insomnia; PTSD; Healthy Participants

Outcome Measures

Primary Outcomes (2)

• NW efficacy towards sleep quality improvement

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

  30 days

• 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.

  30 days

Study Arms (2)

Control Arm

SHAM COMPARATOR

Participants assigned to the sham intervention receive an outwardly identical NightWare smartwatch that does not deliver haptic interventions in response to stress physiology. The sham device collects the same passive physiological data but does not actively attempt to modify sleep or autonomic activity. This arm controls for placebo effects, device expectations, and nightly wear. Participants follow the same 30-day procedures, including daily surveys and physiological sensor wear, ensuring all aspects of participation are identical except for the therapeutic haptic function.

Device: Sham (No Treatment)

Intervention Arm

EXPERIMENTAL

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.

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

Interventions

Sham (No Treatment) DEVICE

NW device that does not deliver any intervention

Control Arm

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.

Intervention Arm

Eligibility Criteria

• Age: 18 Years - 62 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uniformed Services University of the Health Sciences: lead
• University of Minnesota: collaborator
• The Geneva Foundation: collaborator
• National Intrepid Center of Excellence: collaborator
• Walter Reed National Military Medical Center: collaborator
• Henry M. Jackson Foundation for the Advancement of Military Medicine: collaborator
• Applied Physics Laboratory: collaborator

Study Sites (2)

Walter Reed National Military Medical Center/Uniformed Services University

Bethesda, Maryland, 20814, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (22)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Sleep Wake Disorders; REM Sleep Behavior Disorder

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; REM Sleep Parasomnias; Parasomnias

Central Study Contacts

Kent Werner, MD/PhD

CONTACT

3012953840; kent.werner@usuhs.edu

Elizabeth Metzger

CONTACT

elizabeth.metzger.ctr@usuhs.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Research Coordinators, Research Assistants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This study uses a double-blind, randomized, sham-controlled interventional model to test whether the NightWare smartwatch improves sleep quality in warfighters with insomnia and symptoms of sympathetic hyperactivity. Eligible participants from Phase 1 enter a 30-day at-home intervention and are randomly assigned to receive either an active NightWare device or an identical sham device. Neither participants nor study staff know the assignment. All participants wear multiple validated physiological sensors and complete brief daily surveys to measure sleep, autonomic activity, mood, and treatment response. This design allows objective comparison of active versus sham stimulation and supports development of biomarker-based predictors of treatment effectiveness.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 17, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)