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NightmareINSIGHTNCT07288593

INSIGHT: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention

A study testing NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns. in people with Nightmare and Insomnia, run by Uniformed Services University of the Health Sciences at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 62 yearsHealthy volunteers can take part
Conditions the study is for
Nightmare, Insomnia, PTSD
What is being tested?
NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns.
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
2 sitesUnited States
Study dates
1 Jun 2026to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 62 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 25Show fewer
  • 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.)
  • Metal in body that is ferromagnetic / incompatible with MRI or other safety issues and indicated by screen Previous adverse reactions to sleep deprivation Illicit drug use as determined by participant self-report Alcohol in system at time of MRI overnight as determined participant self report Nicotine use in the last 3 months
  • For poor sleep group:
  • TBI History of epilepsy or suspected seizure disorder.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kent Werner, MD/PhD contact

3012953840

kent.werner@usuhs.edu

Elizabeth Metzger contact

elizabeth.metzger.ctr@usuhs.edu

United States2 sites
  • Walter Reed National Military Medical Center/Uniformed Services University

    Bethesda, Maryland, 20814

    Kent CDR Werner, MD/Ph.D., 301-295-3840, kent.werner@usuhs.edu

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Nicholas Dr. Davenport, Ph.D., 612-626-4430, daven012@umn.edu

Other trials in United States

About this study

Official title: Insomnia, Nightmares, and Sympathetic Hyperactivity Intervention in the warfiGHTer (INSIGHT)

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.

Read the detailed description

Warfighters with mild traumatic brain injury (mTBI) and often comorbid post-traumatic stress disorder (PTSD) are at particularly high risk for disturbed sleep, which undermines performance, psychological health, immune function, and operational readiness. Insomnia is extremely common in these populations, and many report symptoms consistent with nocturnal sympathetic nervous system hyperactivity (SNH), including diaphoresis, hyperarousal, palpitations, tachypnea, and nightmares, which degrade both sleep quality and duration. Insomnia remains one of the most prevalent sleep disorders and is two to three times more common in military and veteran populations than in civilians, with symptoms often lasting decades. Short-term consequences include slowed reaction time, impaired working and visual memory, reduced verbal fluency, and poorer information processing; these changes correlate with hippocampal subregion atrophy in neuroimaging studies. Long-term outcomes include heightened risk of depression, suicidality, cardiovascular disease, cancer, and nearly double the risk of later-life dementia. TBI and PTSD independently impose similar long-term risks, likely compounding insomnia-related impairments. Notably, treating insomnia can improve cognition and even reverse aspects of cortical atrophy in TBI, suggesting that insomnia may be a modifiable mechanism linking these conditions. Military operational exposures increase vulnerability to SNH, offering a plausible explanation for the elevated burden of insomnia in warfighters. Deployment exposure alone has been shown to double insomnia risk, even after accounting for TBI and PTSD. Chronic stress and repeated sleep deprivation, both common in military environments, can produce long-lasting autonomic nervous system (ANS) imbalance and measurable sympathetic excess, including reduced heart rate variability (HRV). Both TBI and PTSD have been independently associated with peripheral and central markers of sympathetic overactivation, including HRV alterations, cardiovascular changes, sweat responses, hormonal patterns, EEG disturbances, and functional MRI findings, with evidence of synergistic effects. SNH relates to insomnia through abnormal HRV, elevated sleeping heart rate and blood pressure, and increased catecholamines and cortisol. Nightmares represent a particularly strong link between stress, PTSD, and SNH. Brain injury affecting the locus coeruleus (LC) is associated with nightmares, and nightmares themselves reflect sympathetic activation. It is therefore plausible that insomnia complaints in warfighters with chronic stress exposure, PTSD, and/or TBI reflect, in part, underlying SNH. Sympathetic tone supports alertness during wakefulness, but excessive activity during sleep is disruptive. The LC drives the fight-or-flight response and activates networks involved in vigilance and threat detection. In healthy sleep, LC activity decreases substantially. Rapid Eye Movement (REM) sleep, critical for emotional processing and dreaming, requires near-silence of the LC, enabling down-regulation of fear circuitry. Excessive LC activation during REM impairs this emotional "resetting" process and likely contributes to nightmare formation. SNH can also produce dream enactment, hyperarousal, startle responses, and peripheral symptoms such as sweating and palpitations. Deep non-REM (NREM) sleep further requires low LC oscillations to allow high-amplitude EEG slow waves, which drive synaptic downscaling, memory consolidation, hormonal rhythms, and cerebrospinal fluid (CSF) flow. These CSF oscillations support glymphatic clearance, the brain's waste-removal system, recently demonstrated in humans via fMRI-EEG studies. Because NREM slow waves support glymphatic activity, and sympathetic activity suppresses these dynamics, warfighters with SNH may experience reduced glymphatic clearance, yet this hypothesis has never been systematically tested in an insomnia population. Insomnia is heterogeneous, and this heterogeneity contributes to inconsistent findings in the literature. Many conditions mimic insomnia or complicate its presentation, including anxiety disorders, circadian misalignment, obstructive sleep apnea (OSA), chronic pain, and reflux. These confounders may explain why some studies fail to replicate associations between insomnia and SNH. Pharmacological targeting of SNH has shown partial success. Prazosin, an alpha-1 adrenergic antagonist, has improved insomnia, nightmares, and cognition in warfighters with PTSD and TBI, though the largest randomized trial in PTSD nightmares did not show benefit, likely in part due to heterogeneous populations and inadequate screening for confounders. Past studies also lacked objective verification of SNH and relied heavily on subjective questionnaires. Gold-standard physiological measures (EEG, fMRI, autonomic monitoring, respiratory signals, and electrodermal activity) are resource-intensive and typically require in-lab recordings, limiting feasibility for large trials. No validated autonomic biomarker currently exists to stratify insomnia patients by SNH burden, highlighting the urgent need for accessible biomarker development. Wearable and "nearable" technologies offer a promising solution. If validated against gold-standard physiological measures, these devices could dramatically expand the ability to capture autonomic and sleep signals in real-world environments. Wearables are comfortable, low-cost, and reduce the artificiality of lab-based sleep measurement. Modern devices measure movement, cardiac and respiratory variability, EEG signals, and electrodermal activity, making them useful for parsing sympathetic and parasympathetic contributions. Sudomotor activity, captured via smartwatches, uniquely reflects pure sympathetic activation. Combined, wearable-derived biomarkers could provide a multidimensional profile of autonomic tone and help stratify patients, monitor treatment effects, and guide intervention development. New approaches to insomnia treatment are needed, particularly for warfighters experiencing SNH. Insomnia is largely defined by self-report, making it difficult to identify mechanistic subtypes. Cognitive Behavioral Therapy for Insomnia (CBTi) remains the gold standard, but access is limited, treatment requires several weeks, and completion rates among warfighters are low. Medications carry notable side effects and are rarely suitable for long-term use. Stellate ganglion block, which reduces peripheral sympathetic output, has shown benefit in PTSD-related hyperarousal and insomnia but is invasive, expensive, and not widely available. A noninvasive, inexpensive, mechanism-targeted option is needed. The NightWare smartwatch represents a promising therapeutic candidate. NightWare is FDA-cleared for treating nightmares; it detects increases in stress physiology via heart rate and movement and delivers brief haptic vibrations to interrupt escalating sympathetic activation. In a prior randomized controlled trial of 75 warfighters with PTSD, poor sleep quality, and frequent nightmares, both sham and active NightWare groups improved, but individuals who wore the device consistently (≥50% of nights) showed significantly greater improvements in sleep quality and nightmare frequency. However, the prior study lacked physiological monitoring to examine how the haptic intervention interacts with sleep stages or autonomic activity. Because NightWare targets sympathetic spikes, it may benefit a broader population of warfighters with insomnia and SNH, even without frequent nightmares. In clinical settings, 20-30% of warfighters endorse nightmares, but many more report other SNH symptoms. This study therefore proposes the first randomized, double-blind, sham-controlled trial to test NightWare in warfighters with insomnia and physiological signs of SNH. A unique feature of the trial is its integration with extensive wearable monitoring and biomarker collection, allowing the device's physiological effects to be characterized in real time. The research will occur in two phases. Phase 1 characterizes baseline sympathetic activity, sleep, cognitive function, self-reported symptoms, and glymphatic markers using a combination of wearable devices, ecological momentary assessments, urine biomarkers, overnight polysomnography, and optional MRI-EEG imaging. Using a diverse array of validated devices allows researchers to capture complementary data streams, such as continuous temperature, high-resolution ECG, EEG, and autonomic signals, necessary for creating a multidimensional profile of sleep and autonomic function. A subset of participants will also complete a sleep-deprivation MRI session using the MAGNUS MRI system to enhance sleep depth during scanning. Sleep deprivation increases sleep pressure, enhances NREM3 slow-wave activity, and can reveal physiological abnormalities not evident during normal baseline sleep, making it ideal for assessing glymphatic dynamics. Phase 2 enrolls poor sleepers into a 30-day randomized, double-blind intervention with either active or sham NightWare devices, alongside daily wearable monitoring and ecological momentary assessments. By integrating high-temporal-resolution physiological signals with behavioral data and treatment exposure, the study aims to identify which autonomic markers predict treatment response and to develop a "Multi-Organ Autonomic Index of Sleep" capable of stratifying insomnia subtypes for future personalized interventions. Wearable data will also quantify the immediate physiological impact of haptic feedback events, enabling iterative improvement of treatment algorithms. The INSIGHT study will generate one of the most comprehensive datasets ever collected on the relationships among autonomic activity, sleep architecture, glymphatic function, trauma exposure, and treatment responsiveness in military populations. The findings will advance efforts to understand the biological mechanisms underlying insomnia in warfighters, identify objective biomarkers for patient stratification, and develop scalable, nonpharmacological treatments that improve readiness and long-term neurological health.

Being tested
NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns., Sham (No Treatment)
Keywords
Nightmares, Wearables, Intervention, Sleep quality, Hyperarousal, Insomnia, PTSD, Healthy Participants
Medical subject headings
Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic, Sleep Wake Disorders, REM Sleep Behavior Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT07288593
Study groupRoleWhat they receive
Control ArmSham comparatorParticipants 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.
Receives: Device: Sham (No Treatment)
Intervention ArmExperimentalParticipants 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.
Receives: Device: NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. NW efficacy towards sleep quality improvement

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

    Measured: 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.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2025
  2. Study start1 Jun 2026 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07288593
Sponsor's protocol ID
USUHS.2024-136
Acronym
INSIGHT
Status last verified
Apr 2026
First submitted
10 Dec 2025
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Davenport ND, Werner JK. A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans. J Clin Sleep Med. 2023 Feb 1;19(2):361-369. doi: 10.5664/jcsm.10338.

    PubMed 36305584
  • Naegeli C, Zeffiro T, Piccirelli M, Jaillard A, Weilenmann A, Hassanpour K, Schick M, Rufer M, Orr SP, Mueller-Pfeiffer C. Locus Coeruleus Activity Mediates Hyperresponsiveness in Posttraumatic Stress Disorder. Biol Psychiatry. 2018 Feb 1;83(3):254-262. doi: 10.1016/j.biopsych.2017.08.021. Epub 2017 Sep 7.

    PubMed 29100627
  • Sara SJ. The locus coeruleus and noradrenergic modulation of cognition. Nat Rev Neurosci. 2009 Mar;10(3):211-23. doi: 10.1038/nrn2573. Epub 2009 Feb 4.

    PubMed 19190638
  • George SA, Knox D, Curtis AL, Aldridge JW, Valentino RJ, Liberzon I. Altered locus coeruleus-norepinephrine function following single prolonged stress. Eur J Neurosci. 2013 Mar;37(6):901-9. doi: 10.1111/ejn.12095. Epub 2012 Dec 20.

    PubMed 23279008
  • Lampert R, Tuit K, Hong KI, Donovan T, Lee F, Sinha R. Cumulative stress and autonomic dysregulation in a community sample. Stress. 2016 May;19(3):269-79. doi: 10.1080/10253890.2016.1174847. Epub 2016 Apr 25.

    PubMed 27112063
  • Caldwell JA, Knapik JJ, Shing TL, Kardouni JR, Lieberman HR. The association of insomnia and sleep apnea with deployment and combat exposure in the entire population of US army soldiers from 1997 to 2011: a retrospective cohort investigation. Sleep. 2019 Aug 1;42(8):zsz112. doi: 10.1093/sleep/zsz112.

    PubMed 31106808
  • Raikes AC, Dailey NS, Forbeck B, Alkozei A, Killgore WDS. Daily Morning Blue Light Therapy for Post-mTBI Sleep Disruption: Effects on Brain Structure and Function. Front Neurol. 2021 Feb 5;12:625431. doi: 10.3389/fneur.2021.625431. eCollection 2021.

    PubMed 33633674
  • Sivertsen B, Omvik S, Pallesen S, Bjorvatn B, Havik OE, Kvale G, Nielsen GH, Nordhus IH. Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial. JAMA. 2006 Jun 28;295(24):2851-8. doi: 10.1001/jama.295.24.2851.

    PubMed 16804151
  • Leng Y, Byers AL, Barnes DE, Peltz CB, Li Y, Yaffe K. Traumatic Brain Injury and Incidence Risk of Sleep Disorders in Nearly 200,000 US Veterans. Neurology. 2021 Mar 30;96(13):e1792-e1799. doi: 10.1212/WNL.0000000000011656. Epub 2021 Mar 3.

    PubMed 33658328
  • Yaffe K, Vittinghoff E, Lindquist K, Barnes D, Covinsky KE, Neylan T, Kluse M, Marmar C. Posttraumatic stress disorder and risk of dementia among US veterans. Arch Gen Psychiatry. 2010 Jun;67(6):608-13. doi: 10.1001/archgenpsychiatry.2010.61.

    PubMed 20530010
  • Chen PL, Lee WJ, Sun WZ, Oyang YJ, Fuh JL. Risk of dementia in patients with insomnia and long-term use of hypnotics: a population-based retrospective cohort study. PLoS One. 2012;7(11):e49113. doi: 10.1371/journal.pone.0049113. Epub 2012 Nov 7.

    PubMed 23145088
  • Yaffe K, Nettiksimmons J, Yesavage J, Byers A. Sleep Quality and Risk of Dementia Among Older Male Veterans. Am J Geriatr Psychiatry. 2015 Jun;23(6):651-4. doi: 10.1016/j.jagp.2015.02.008. Epub 2015 Feb 21.

    PubMed 25794635
  • Sexton CE, Storsve AB, Walhovd KB, Johansen-Berg H, Fjell AM. Poor sleep quality is associated with increased cortical atrophy in community-dwelling adults. Neurology. 2014 Sep 9;83(11):967-73. doi: 10.1212/WNL.0000000000000774. Epub 2014 Sep 3.

    PubMed 25186857
  • von Ruesten A, Weikert C, Fietze I, Boeing H. Association of sleep duration with chronic diseases in the European Prospective Investigation into Cancer and Nutrition (EPIC)-Potsdam study. PLoS One. 2012;7(1):e30972. doi: 10.1371/journal.pone.0030972. Epub 2012 Jan 25.

    PubMed 22295122
  • Cappuccio FP, Miller MA. Sleep and Cardio-Metabolic Disease. Curr Cardiol Rep. 2017 Sep 19;19(11):110. doi: 10.1007/s11886-017-0916-0.

    PubMed 28929340

Questions about this trial

What is this clinical trial studying?

A study testing NightWare smartwatch configured to detect physiological signs of sympathetic activation during sleep, such as heart-rate spikes and movement patterns. in people with Nightmare and Insomnia, run by Uniformed Services University of the Health Sciences at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kent Werner, MD/PhD (3012953840, kent.werner@usuhs.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

NW efficacy towards sleep quality improvement (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07288593, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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