Digital Therapeutic for Sleep in Post-Traumatic Stress Disorder
(TNT/NW Trial)
Recruiting at 4 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: NightWare
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial tests the NightWare system, which uses an Apple Watch and iPhone app to help people with PTSD-related nightmares. The watch detects when a nightmare is starting and vibrates to stop it without waking the person up. This aims to improve sleep quality for those who suffer from frequent nightmares.
Research Team
DR
Daniel R Karlin, MD MA
Principal Investigator
NightWare
Eligibility Criteria
This trial is for adults over 22 with PTSD-related nightmares disrupting sleep, a PSQI score of 10+, and no current use of certain medications like varenicline or beta-blockers. Participants need internet, power outlets by their bed, and can't have conditions like sleep apnea or narcolepsy. Veterans in specific VA hospitals are eligible.Inclusion Criteria
You have been diagnosed with PTSD based on the criteria set by the American Psychiatric Association in their DSM-5 manual.
You have a high score of 10 or more on the Pittsburgh Sleep Quality Index, indicating poor sleep quality.
I have stopped taking prazosin 2 days before joining.
See 10 more
Exclusion Criteria
I have been diagnosed with a sleep disorder where I act out dreams.
I have been diagnosed with narcolepsy.
You have a history of acting out your dreams before experiencing a traumatic event that caused PTSD.
See 16 more
Treatment Details
Interventions
- NightWare Therapeutic System (Behavioural Intervention)
- Sham NightWare (Behavioural Intervention)
Trial OverviewThe study tests the NightWare system (iPhone + Apple Watch app) against a sham device to see if it improves sleep quality for those with PTSD-related nightmares. It's hypothesized that NightWare will significantly enhance sleep.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Intervention with NightWare Therapeutic System
Group II: Sham ArmPlacebo Group1 Intervention
NightWare system set to not provide any interventions
Find a Clinic Near You
Who Is Running the Clinical Trial?
NightWare
Lead Sponsor
Trials
5
Recruited
800+
James A. Haley Veterans Administration Hospital
Collaborator
Trials
21
Recruited
13,200+
Minneapolis Veterans Affairs Medical Center
Collaborator
Trials
77
Recruited
355,000+
Louis Stokes VA Medical Center
Collaborator
Trials
21
Recruited
4,100+
Walter Reed National Military Medical Center
Collaborator
Trials
149
Recruited
33,800+
Fort Belvoir Community Hospital
Collaborator
Trials
15
Recruited
2,100+