NightWare Open Enrollment Study

NCT03828656 | Unknown FDA Device

• 1 other identifier: NW101003
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide measures 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

PostTraumatic Stress Disorder; Sleep Disorder; Stress Disorder; Sleep Initiation and Maintenance Disorders; Combat Disorders; Nightmares Associated With Chronic Post-Traumatic Stress Disorder; Nightmare; Nightmares, REM-Sleep Type

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period

  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 post-treatment initiation assessments (Days 14, 28 and every 28 days after that).

  0-730 days

Study Arms (1)

Open Label Treatment Arm

EXPERIMENTAL

Open-label Intervention with the NightWare Therapeutic System every night.

Device: NightWare Therapeutic System

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.

Open Label Treatment Arm

Eligibility Criteria

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

You may qualify if:

• New to NightWare
• Self report of diagnosis with PTSD
• Self-report of PTSD-related repetitive nightmares contributing to disrupted sleep.
• Equal to or older than 18 years of age.
• Proficient in both reading and writing in the English language.
• Pittsburgh Sleep Quality Index (PSQI) score equal to or greater than 10.
• ESS: On question #8 any score above "0" will prompt an additional question:
• Do you drive ("get behind the wheel") when you are drowsy?
• Answer must be "No" to be enrolled in the study for safety.
• Participant owns or has access to devices appropriate for participation in the study including compatible Apple Watch and Apple iPhone.
• Wireless Internet and two power outlets where they sleep.
• Current NightWare user - Is a participant in current NightWare consumer preference study or has successfully completed any NightWare study protocol.

You may not qualify if:

• New to NightWare
• Circadian rhythm disruption on a regular basis (shift-work)
• Concurrent presence of prohibited diagnoses
• Known diagnosis of OSA
• Diagnosis of an active disorder of arousal from non-rapid eye movement sleep
• Diagnosis of rapid eye movement sleep behavior disorder
• Diagnosis of narcolepsy
• Diagnosis of dementia
• Uncontrolled atrial fibrillation
• Use of Alcohol or Drugs as specified:
• 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
• Previous or foreseeable legal proceedings involving nightmares or trauma
• Nocturia that causes awakening from sleep

Sponsors & Collaborators

• NightWare: lead
• RationalPsych: collaborator
• Center for International Emergency Medical Services: collaborator

Study Sites (1)

RationalPsych

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Sleep Wake Disorders; Stress Disorders, Traumatic; Sleep Initiation and Maintenance Disorders; Combat Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel R Karlin, MD MA

  RationalPsych

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: February 4, 2019
• Study Start: February 1, 2019
• Primary Completion: February 1, 2022
• Study Completion: February 1, 2022
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)