Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934658
Other study ID # NW101004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 21, 2019
Est. completion date December 15, 2021

Study information

Verified date January 2022
Source NightWare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date December 15, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria - 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. - Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare. Exclusion Criteria - Circadian rhythm disruption on a regular basis (shift-work) - Concurrent presence of prohibited medications - 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 subjects 2 weeks post-taper and discontinuation) - 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 - Self reported pregnancy or intent to become pregnant during the course of the study

Study Design


Related Conditions & MeSH terms


Intervention

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.
NightWare Therapeutic System in Sham Mode
A wearable digital therapeutic system that will measure physiologic data when worn during sleep that does not deliver interventions.

Locations

Country Name City State
United States RationalPsych Bronx New York

Sponsors (3)

Lead Sponsor Collaborator
NightWare Center for International Emergency Medical Services, RationalPsych

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT03384706 - A Comparison of CPT Versus ART Versus WL N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Completed NCT03129204 - Sensation Awareness Focused Training for Spouses N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT05113277 - Development and Evaluation of a Tonic Immobility Focused Psychoeducational Intervention N/A
Recruiting NCT05327504 - Written Exposure Therapy for Veterans With SUD and PTSD N/A
Recruiting NCT05843695 - Enhancing Psychotherapy for Veterans and Service Members With PTSD and Anxiety N/A
Active, not recruiting NCT05530642 - An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel N/A
Completed NCT00644423 - Omega-3 Fatty Acids and Post Traumatic Stress Disorder (PTSD) N/A
Completed NCT02989987 - NET for SGBV Survivors in Eastern DR Congo N/A
Completed NCT02320799 - Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya N/A
Recruiting NCT02293291 - Thermal Clinic Treatment in Gulf War Illness Phase 1/Phase 2
Completed NCT02242136 - Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants N/A
Completed NCT02720497 - The Efficacy of 90-Minute Versus 60-Minute Sessions of Prolonged Exposure for PTSD N/A
Completed NCT01911585 - Efficacy of 60-minute Versus 90-minute Sessions in Treating PTSD Using Prolonged Exposure N/A
Terminated NCT01408641 - Topiramate for Alcohol Use in Posttraumatic Stress Disorder N/A
Completed NCT01693978 - Contingency Outcomes in Prolonged Exposure N/A
Completed NCT01469754 - Longitudinal Survey Analysis in Lymphoma Survivors N/A
Completed NCT02362477 - Telemental Health and Cognitive Processing Therapy for Female Veterans With Military-related PTSD Phase 3
Terminated NCT01239173 - Emotional Memory Reactivation in Posttraumatic Stress Disorder Phase 3