Last reviewed · How we verify
NCT04040387: TNT/NW
NightWare Randomized Trial 02
NA trial testing NightWare Therapeutic System in Stress Disorders, Post-Traumatic in 270 participants. Completed in 2 August 2025.
31 May 2025
Quick facts
| Lead sponsor | NightWare |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 270 |
| Start date | 24 July 2019 |
| Primary completion | 31 May 2025 |
| Estimated completion | 2 August 2025 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- NightWare Therapeutic System
- Sham NightWare
Conditions studied
- Stress Disorders, Post-Traumatic — all drugs for Stress Disorders, Post-Traumatic →
- Combat Disorders — all drugs for Combat Disorders →
- Ptsd — all drugs for Ptsd →
- Nightmare — all drugs for Nightmare →
Sponsor
NightWare
Who can join
22 and older, any sex, with Stress Disorders, Post-Traumatic or Combat Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A randomized sham-controlled clinical trial of a novel wearable intervention for trauma-related nightmares in military veterans.
Davenport ND, Werner JK. · · 2023 · cited 12× · PMID 36305584 · DOI 10.5664/jcsm.10338
Verify or expand the search:
- PubMed search for NCT04040387
- 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.
- NCT03934658 — Remote Study of NightWare for PTSD With Nightmares · NA · completed
- NCT03795987 — Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken) · NA · completed
- NCT03828656 — NightWare Open Enrollment Study · NA · unknown
Other recruiting trials for Stress Disorders, Post-Traumatic
Currently open trials in the same condition.
- NCT07422077 — Impact of ERCS on Perceived Stress in Patients Hospitalized in the Post-resuscitation Rehabilitation Service · NA · recruiting
- NCT07010770 — SMART Therapist Training: A Hybrid Factorial-SMART Design · NA · recruiting
- NCT06852469 — Computational Assessment of GABA Receptor Modulation in PTSD · Phase 4 · recruiting
- NCT06000475 — Enhancing Memory in CPT for PTSD · NA · recruiting
- NCT06355284 — Overcontrol and Suicide in PTSD · active not recruiting
Other NightWare trials
Trials by the same sponsor.
- NCT03934658 — Remote Study of NightWare for PTSD With Nightmares · 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 NCT04040387 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 14 April 2026
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/NCT04040387.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing