NightWare Randomized Trial 02

NCT04040387 | Completed FDA Device

• 1 other identifier: NW101002
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 4

Brief Summary

This study will provide preliminary estimates of safety and efficacy of the NightWare digital therapeutic system (iPhone + Apple watch + proprietary application) for the treatment of nightmare disorder associated with post-traumatic stress disorder (PTSD)-related sleep disturbance and the impact of improved sleep with the NightWare digital therapeutic system. The investigators hypothesize that the NightWare digital therapeutic system will significantly improve sleep quality in participants with PTSD-Related nightmares and poor sleep quality.

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders; Ptsd; Nightmare; Nightmares, REM-Sleep Type; Nightmare Disorder With Associated Non-Sleep Disorder

Keywords

PTSD; Nightmare; Nightmare Disorder; Post-traumatic stress disorder; Veteran; Digital therapeutic; Digital medicine; Military

Outcome Measures

Primary Outcomes (1)

• Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to Day 30

  The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. This outcome is the difference between the global score on the Pittsburgh Sleep Quality Index (PSQI) score at baseline (Day 0) and average global PSQI score across the four post-treatment initiation assessments (Days 14, 30, 44 and 60).

  0-90 days

Secondary Outcomes (1)

• change in PSQI from 0-90 days

  90 days

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Intervention with NightWare Therapeutic System

Device: NightWare Therapeutic System

Sham Arm

SHAM COMPARATOR

NightWare system set to not provide any interventions

Device: Sham NightWare

Interventions

NightWare Therapeutic System DEVICE

A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.

Treatment Arm

Sham NightWare DEVICE

NightWare device not providing interventions

Sham Arm

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans and Active-Duty Service Member Enrolled in the Minneapolis/St. Cloud VAHCS, Louis Stokes VAHCS in Cleveland, Walter Reed National Military Medical Center, or Fort Belvoir Community Hospital
• Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
• Equal to or older than 22 years of age.
• Proficient in both reading and writing in the English language.
• Pittsburgh Sleep Quality Index (PSQI) score 10 or higher.
• Epworth Sleepiness Scale (ESS): On question #8 any score above "0" will prompt an additional question: Do you drive ("get behind the wheel") when you are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns.
• Have repetitive nightmares contributing to disrupted sleep as reported by the patient
• Wireless Internet and two power outlets where they sleep
• Prazosin use; if yes, the patient may be included if tapered by prescribing provider. Taper must be completed and subject must be off prazosin for 2 days prior to enrollment.

You may not qualify if:

• Patient Health Questionnaire-9 (PHQ-9) score greater than or equal to 20. A score of 1 or more on the suicide ideation item of the PHQ-9 will trigger a risk assessment.
• Uncontrolled atrial fibrillation
• Current use of varenicline
• Current use of beta-blockers (unless ophthalmic solutions)
• Current use of non-dihydropyridines
• Current use of Prazosin for the treatment of nightmares (can include patients 2 days following taper and discontinuation) This would be coordinated with the prescribing provider
• Circadian rhythm disruption on a regular basis (shift-work)
• Untreated Obstructive Sleep Apnea
• Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
• Diagnosis of rapid eye movement sleep behavior disorder
• Diagnosis of narcolepsy
• Alcohol Use Disorders Inventory Test (AUDIT) (score of 8 or higher)
• Drug Abuse Screening Test-10 (DAST-10) (score greater than 2)
• Suspicion of nightmares being secondary to substance abuse or withdrawal
• Diagnosis or suspicion of dementia

Sponsors & Collaborators

• Ralph H. Johnson VA Medical Center: collaborator
• NightWare: lead
• Minneapolis Veterans Affairs Medical Center: collaborator
• Louis Stokes VA Medical Center: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (4)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20814, United States

Location

Minneapolis VA Healthcare System

Minneapolis, Minnesota, 55417, United States

Location

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

Ralph H Johnson Veterans Affairs Medical Center

Charleston, South Carolina, 29401, United States

Location

Related Publications (1)

• 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.

  PMID: 36305584 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Daniel R Karlin, MD MA

  NightWare

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: July 24, 2019
• Primary Completion: May 31, 2025
• Study Completion: August 2, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)