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Behavioural Intervention

NightWare for PTSD

N/A
Waitlist Available
Led By Kerrie L Moreau, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 22 years or older
Poor overall sleep quality as indicated by a Pittsburgh Sleep Quality Index (PSQI) score of 6 or higher
Must not have
Use of insulin or sulfonylureas
Unstable medical condition (e.g., uncontrolled hypertension or active CVD or cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured before and after 8 weeks of nightware and sham conditions

Summary

This trial aims to see if a prescription wrist-wearable device called NightWare can help Veterans with PTSD-related nightmares sleep better. Researchers also want to find out if using this device can improve the cardiovascular health

Who is the study for?
This trial is for veterans with PTSD who frequently experience nightmares. Participants should be interested in testing a wrist-wearable device called NightWare, aimed at improving sleep and potentially cardiovascular health.
What is being tested?
The study tests the effectiveness of NightWare, a prescription device worn on the wrist during sleep. It's designed to help veterans with PTSD by reducing nightmares and possibly enhancing cardiovascular health.
What are the potential side effects?
Since NightWare is a non-invasive wearable device, it may have minimal side effects compared to medication. Potential side effects are not detailed but could include discomfort from wearing the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 22 years old or older.
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I have poor sleep quality, with a PSQI score over 6.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I use insulin or sulfonylureas for my diabetes.
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I do not have any uncontrolled health conditions like high blood pressure or active heart disease.
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I wake up at night because I need to urinate.
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I have a history of sleepwalking or acting out dreams.
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I have a seizure disorder.
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I do not have severe mental health issues that would stop me from participating.
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I have been diagnosed with or suspected to have dementia.
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I have been diagnosed with a sleep disorder affecting my sleep stages or narcolepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured before and after 8 weeks of nightware and sham conditions
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured before and after 8 weeks of nightware and sham conditions for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Pittsburgh Sleep Quality Index
Secondary study objectives
Change in Autonomic function - spontaneous baroreflex sensitivity (BRS)
Change in autonomic function - heart rate variability (HRV)
Change in endothelial function
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: NightWare activeExperimental Treatment1 Intervention
Intervention with NightWare Therapeutic System
Group II: NightWare ShamPlacebo Group1 Intervention
NightWare app disabled; device will not deliver an intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NightWare
2022
N/A
~40

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,565 Total Patients Enrolled
Kerrie L Moreau, PhDPrincipal InvestigatorRocky Mountain Regional VA Medical Center, Aurora, CO
3 Previous Clinical Trials
202 Total Patients Enrolled
~83 spots leftby Sep 2026
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