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CompletedNCT04040387

NightWare study 02

This study is completed. It focuses on PTSD and currently lists study information in the United States.

PTSD, Combat Disorders, ...DeviceOver 22 Years
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In plain English

Key information made simple

What is this study testing?

This study is testing whether NightWare Therapeutic System may be useful for adults experiencing ptsd.

What would participation involve?

Participants may use NightWare Therapeutic System, complete questionnaires or follow-up assessments, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in the United States.

Who is it mainly for?

This study appears to be mainly for adults with ptsd.

What should you check before joining?

Ask about whether participation can be remote and what device access is needed, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

What to expect

Your next step

The official record does not clearly describe the visit format, so the practical details are best checked directly in the source. Participation appears to involve study activities and follow-up chosen by the research team. The main fit and exclusions are best confirmed in the eligibility section of the official record. The phase details are not clearly stated here.

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: July 24, 2019
Recruitment status
Completed
Estimated enrollment
270
Sponsor
NightWare
Sponsor type
Unknown or unclear
Study type
Device
Intervention type
DEVICE
Study phase
Not clearly listed
Locations
United States
Age range
Over 22 Years
Official registry ID
NCT04040387
Official title
TNT/NW: Traumatic Nightmares Treated by NightWare (To Arouse Not Awaken)
Official source
Official registry link

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Study ID: NCT04040387. We help you review the study, but cannot decide medical eligibility.
In practice

For you

Taking part may give access to a new approach being evaluated.

It requires regular follow-up, often through questionnaires or interviews.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

Based on the public registry summary, this study is trying to understand: 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. The study team can confirm the exact objective and what it means for you.

Does this study involve a device, app, or technology?

This appears to be a device / app / digital / technology study involving NightWare Therapeutic System, Sham NightWare. The phase is not clearly listed in the public registry. Phase is mostly relevant for medication studies and some device studies. For this study, it may be more useful to look at what is required, the duration, visits, and eligibility criteria.

Who might this study be for?

This study may concern people with ptsd; age range: Over 22 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to use a device, app, or digital tool for a defined period. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What should I check about data, monitoring, alerts, and daily use?

If the study uses a device, app, or digital tool, check what data is collected, who can access it, how often you need to use it, and what happens if the tool detects a concerning signal. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by NightWare, which appears to be unknown or unclear. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The registry indicates that this study is completed. It may still be useful for understanding the research, but you are unlikely to be able to join. The registry lists an estimated enrollment of 270 participants.

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