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| Name | Class |
|---|---|
| Minneapolis Veterans Affairs Medical Center | FED |
| Louis Stokes VA Medical Center | FED |
| Walter Reed National Military Medical Center | FED |
| Ralph H. Johnson VA Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | Intervention with NightWare Therapeutic System |
|
| Sham Arm | Sham Comparator | NightWare system set to not provide any interventions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in PSQI from 0-90 days | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel R Karlin, MD MA | NightWare | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20814 | United States | ||
| Minneapolis VA Healthcare System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36305584 | Derived | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 6, 2023 | May 19, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 6, 2023 | Apr 1, 2026 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: WRNMMC ICF | Feb 21, 2024 | May 19, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: CSVA ICF | Jul 28, 2023 | May 19, 2025 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Master ICF | Feb 16, 2024 | May 19, 2025 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: Cleveland ICF | Mar 15, 2023 | May 19, 2025 | ICF_005.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003130 | Combat Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| FED |
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| Sham NightWare | Device | NightWare device not providing interventions |
|
| Minneapolis |
| Minnesota |
| 55417 |
| United States |
| Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44106 | United States |
| Ralph H Johnson Veterans Affairs Medical Center | Charleston | South Carolina | 29401 | United States |