NightWare for PTSD

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byKerrie Moreau, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing NightWare, an app that works with an Apple Watch to help adults with PTSD who have nightmares. The app tracks sleep patterns and uses gentle vibrations to interrupt nightmares without waking the person. The goal is to see if this improves sleep quality and heart health.

Research Team

Kerrie Moreau, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

Adults over 22 with PTSD and repetitive nightmares disrupting sleep, non-smokers, not currently using certain medications or supplements, with controlled blood pressure and glucose levels. Must have internet access for the device used in the trial and agree to avoid other heart rate monitoring apps.

Inclusion Criteria

I don't take vitamins or anti-inflammatory drugs, or I can stop them a month before the vascular visit.

Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare

Non-smokers

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Exclusion Criteria

Acting out of dreams prior to PTSD trauma

Participants will be excluded if they report elevated acute risk for suicidal self-directed violence warranting immediate intervention (e.g., suicidal ideation with intent, evaluated by the Columbia-Suicide Severity Rating Scale [C-SSRS])

My high blood pressure is not under control.

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Treatment Details

Interventions

NightWare (Behavioural Intervention)
Sham NightWare (Behavioural Intervention)

Trial OverviewThe study is testing NightWare, a therapeutic intervention aimed at improving sleep quality by reducing nightmares related to PTSD. It will be compared against a Sham (fake) NightWare to see if it can improve cardiovascular health markers.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NightWareExperimental Treatment1 Intervention

In individuals randomized to the active condition, when the stress index is reached during sleep, NightWare will intervene with varying degrees of vibratory stimulation to the watch over a variable length of time to arouse the person out of the nightmare without awaking.

Group II: Sham NightWarePlacebo Group1 Intervention

In individuals randomized to the sham condition, the NightWare intervention will not be enabled.