Nightmare

7

Review clinical trials related to Nightmare. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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 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.

Participants needed: 180
Trial details
Age: 18-62Biological sex: AllType: InterventionalSponsor: Uniformed Services University of the Health SciencesUpdated: Apr 28, 2026Locations: 2
Eligibility criteria

Defense Enrollment Eligibility Reporting System (DEERS) Eligible [+5]

Use of alpha or beta-receptor active medications or prescribed sleep aids in the... [+21]

Status: Recruiting

Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder

The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their family members (a partner or other family member residing in the same home). All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their family members will attend 2 of those sessions with them.

Participants needed: 20
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Mar 12, 2026Locations: 1
Eligibility criteria

Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease [+7]

Possible dementia [+9]

Status: Not yet recruiting

Decreasing Nightmares in Adults With Narcolepsy

The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment. Romantic partners of participants with narcolepsy will also be eligible to enroll in the study. Partners will complete three assessments but will not participate in the treatment.

Participants needed: 80
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: University of UtahUpdated: Mar 10, 2026Locations: 1
Eligibility criteria

Diagnosis of narcolepsy type 1 or narcolepsy type 2 [+5]

Currently engaged in trauma- or sleep-related psychotherapy [+7]

Status: Recruiting

Art Therapy and Emotional Well Being in Military Populations With Posttraumatic Stress Symptoms

Art therapy is used across the Military Health System for treatment of posttraumatic symptoms, but there is limited research on how art therapy is able to restore emotional expression and regulation in service members. This research hopes to learn about the effects of art therapy on emotional expression and regulation in service members as well as the neurological systems at work. If a participant chooses to be in this study, he or she will attend eleven sessions over a period of six to eight months. The first session will be an interview and self-assessment questionnaires to collect information on a variety of symptoms, experiences, and personality traits, and an MRI scan. During the MRI scan, participants will be asked to perform a task where they will be shown a series of neutral and negative images. The following eight sessions will be one-hour art therapy sessions with a certified art therapist. The tenth session will consist of the same self-assessment questionnaires and another MRI scan. The final session will consist of some of the same questionnaires from the tenth visit, as well as a qualitative interview done virtually three months after the tenth visit.

Participants needed: 40
Trial details
Age: 18-64Biological sex: AllType: InterventionalSponsor: Walter Reed National Military Medical CenterUpdated: Jan 8, 2026Locations: 2
Eligibility criteria

DEERS Eligible [+2]

History of moderate, severe, or penetrating brain injury [+9]

Status: Recruiting

NightWare and Cardiovascular Health in Veterans With PTSD

The purpose of this study is to learn more about the effectiveness of a prescription wrist-wearable device called NightWare (NW) on improving sleep in Veterans with nightmares related to posttraumatic stress disorder (PTSD). The investigators also want to learn whether it improves cardiovascular health among this population.

Participants needed: 125
Trial details
Age: 22-88Biological sex: AllType: InterventionalSponsor: VA Office of Research and DevelopmentUpdated: Sep 12, 2025Locations: 1
Eligibility criteria

Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria... [+8]

Unstable medical condition (e.g., uncontrolled hypertension or active CVD or can... [+13]

Status: Not yet recruiting

NightWare and Cardiovascular Health in Women With PTSD

The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular and renal function in premenopausal women with PTSD-related nightmares, and examine whether these improvements restore them to levels observed in age-matched women without PTSD.

Participants needed: 36
Trial details
Age: 22-40Biological sex: FemaleType: InterventionalSponsor: University of Colorado, DenverUpdated: Jun 13, 2025Locations: 2
Eligibility criteria

Healthy, as determined by medical history [+10]

Pre-existing (e.g., diabetes, liver, kidney disease) or unstable medical conditi... [+19]

Status: Recruiting

Nightmare Deconstruction and Reprocessing vs. NightWare Wristband

The overall goal of this Phase IIa randomized controlled pilot trial is to assess the potential efficacy of two emerging treatments for post-trauma nightmares and to test the feasibility of study design and methods. Symptom change will be assessed in two treatment arms: (1) Nightmare Deconstruction and Reprocessing (NDR), an exposure-based psychotherapy; and (2) NightWare (NW), a non-exposure approach using a wristband device. The investigators will also assess the feasibility of circadian-dependent blood sampling and use of another wristband to collect physiologic data. Specific aims are: (1) Compare evidence of how well participants tolerate and comply with the two treatments and test feasibility of methods and procedures; (2) Collect additional evidence of the potential efficacy of two contrasting non-pharmacologic approaches to treating posttraumatic nightmares; (3) Explore the operational stress index (OSI) as a reliable, objective measure of sleep disturbance and nightmare events.

Participants needed: 30
Trial details
Phase: Phase 2Age: 22-64Biological sex: AllType: InterventionalSponsor: Uniformed Services University of the Health SciencesUpdated: Mar 30, 2025Locations: 1
Eligibility criteria

Active duty service members and veterans [+3]

Serious risk of suicide [+10]