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NightWare Open Enrollment Study (NWOES)

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ClinicalTrials.gov Identifier: NCT03828656
Recruitment Status : Enrolling by invitation
First Posted : February 4, 2019
Last Update Posted : March 4, 2021
Sponsor:
Collaborators:
RationalPsych
Center for International Emergency Medical Services
Information provided by (Responsible Party):
NightWare

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Device: NightWare Therapeutic System Not Applicable

Detailed Description:

Nightmares are a common problem affecting 2-8% of the general population and a higher proportion of clinical populations. The negative consequences of untreated nightmares are significant and include impaired quality of life, sleep deprivation (often resulting in an increased intensity of nightmares), insomnia, daytime sleepiness, and fatigue. Untreated nightmares can also exacerbate the symptoms of underlying psychological dysfunction in people with depression and anxiety, leading to poor occupational and or social functioning. Nightmares can be idiopathic or associated with the use (or withdrawal) of certain medications or substances or associated with disorders including PTSD.

NightWare (Minneapolis, MN) has developed a novel approach to the treatment of nightmares. Through the use of a smartwatch-based application that senses physiologic parameters, the participant is aroused from sleep (without awakening the participant) so that the nightmare is interrupted prior to reaching a threshold of severity in which the participant would awaken in distress. Seconds later the participant returns to sleep without having experienced a nightmare. This approach avoids risk from pharmacological treatment, avoids exacerbation of symptoms from image rehearsal therapy and allows for a simple method with easily achieved adherence compared to existing treatments.

The NightWare digital therapeutic system consists of a proprietary software application installed on a smartwatch. The application has been effective in focus groups when used on both Apple smartwatches and Motorola smartwatches. For the purposes of this study, the investigators will be using only the Apple (Cupertino, CA) 3rd generation smartwatch and the Apple iPhone. The NightWare application uses physiological markers obtained via the smartwatch to determine by proprietary algorithm whether a participant is in the early stages of a nightmare, but has not yet awoken in distress. As directed by the algorithm, the smartwatch then applies varying degrees of vibratory stimulation to the wrist over variable lengths of time with the intention of arousing the participant from sleep without eliciting an awakening.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NightWare Open Enrollment Study
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label Treatment Arm
Open-label Intervention with the NightWare Therapeutic System every night.
 Device: NightWare Therapeutic System
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in global score on the Pittsburgh Sleep Quality Index (PSQI) from Day 0 to each subsequent 28 day evaluation period [ Time Frame: 0-730 days ]
    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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

OR

Current NightWare user - Is a participant in current NightWare consumer preference study or has successfully completed any NightWare study protocol.

Exclusion Criteria:

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
  • Known sleep walking
  • Acting out of dreams PRIOR to PTSD trauma
  • Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare.

OR

Current NightWare User

- No known adverse reaction to the use of the NightWare system.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828656


Locations
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United States, New York
RationalPsych
Bronx, New York, United States, 10461
Sponsors and Collaborators
NightWare
RationalPsych
Center for International Emergency Medical Services
Investigators
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Principal Investigator: Daniel R Karlin, MD MA RationalPsych
More Information
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Responsible Party: NightWare
ClinicalTrials.gov Identifier: NCT03828656    
Other Study ID Numbers: NW101003
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NightWare:
PTSD
Nightmare Disorder
Post-traumatic stress disorder
Veteran
 Digital therapeutic
Digital medicine
Nightmares
Additional relevant MeSH terms:
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Sleep Wake Disorders
Sleep Initiation and Maintenance Disorders
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Combat Disorders
Pathologic Processes
 Trauma and Stressor Related Disorders
Mental Disorders
Nervous System Diseases
Neurologic Manifestations
Sleep Disorders, Intrinsic
Dyssomnias