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NCT03934658: NWVRCT
Remote Study of NightWare for PTSD With Nightmares
NA trial testing NightWare Therapeutic System in PostTraumatic Stress Disorder in 81 participants. Completed in 15 December 2021.
15 December 2021
Quick facts
| Lead sponsor | NightWare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 81 |
| Start date | 21 May 2019 |
| Primary completion | 15 December 2021 |
| Estimated completion | 15 December 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- NightWare Therapeutic System
- NightWare Therapeutic System in Sham Mode
Conditions studied
- PostTraumatic Stress Disorder — all drugs for PostTraumatic Stress Disorder →
- Sleep Disorder — all drugs for Sleep Disorder →
- Stress Disorder — all drugs for Stress Disorder →
- Sleep Initiation and Maintenance Disorders — all drugs for Sleep Initiation and Maintenance Disorders →
Sponsor
NightWare
Who can join
18 and older, any sex, with PostTraumatic Stress Disorder or Sleep Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03934658
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of NightWare Therapeutic System
Trials testing the same drug.
- NCT04040387 — NightWare Randomized Trial 02 · NA · completed
- NCT03795987 — Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) · NA · completed
- NCT03828656 — NightWare Open Enrollment Study · NA · unknown
Other NightWare trials
Trials by the same sponsor.
- NCT04040387 — NightWare Randomized Trial 02 · NA · completed
- NCT03795987 — Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) · NA · completed
- NCT03828656 — NightWare Open Enrollment Study · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03934658 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by NightWare
- Last refreshed: 28 January 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03934658.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing