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Behavioural Intervention

NightWare for PTSD

N/A
Recruiting
Led By Kerrie Moreau, PhD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Self-report having repetitive nightmares contributing to disrupted sleep
Be older than 18 years old
Must not have
Uncontrolled hypertension
Diagnosis of narcolepsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured before and after 6 weeks of nightware and sham conditions
Awards & highlights

Summary

This trial will test whether a new app can help improve symptoms for people with PTSD who have nightmares.

Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Since NightWare is a digital therapeutic intervention focusing on improving sleep patterns through technology rather than medication, side effects are minimal but may include discomfort due to wearing the device or potential disruption of sleep from alerts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I often have nightmares that disturb my sleep.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not under control.
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I have been diagnosed with narcolepsy.
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I have been diagnosed with or suspected to have dementia.
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I have moderate to severe sleep apnea diagnosed or confirmed by a WatchPat test.
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I am currently taking varenicline, beta-blockers (not eye drops), or non-dihydropyridine medications.
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I have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured before and after 6 weeks of nightware and sham conditions
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured before and after 6 weeks of nightware and sham conditions for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in 1utonomic function - BRS
Change in endothelial function
Change in large elastic artery stiffness -carotid artery
Secondary outcome measures
Change in autonomic function - HRV
Change in large elastic artery stiffness
Other outcome measures
Change in C-Reactive Protein
Change in CESD
Change in CSSR-S
+10 more

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Post-Traumatic Stress Disorder (PTSD) include pharmacologic therapies like SSRIs and SNRIs, which increase serotonin and norepinephrine levels to help regulate mood and anxiety. Non-pharmacologic treatments, such as trauma-focused cognitive behavioral therapy (CBT) and exposure therapy, help patients process traumatic memories and reduce avoidance behaviors. Digital therapeutic devices like NightWare aim to reduce nightmares by disrupting the sleep patterns associated with PTSD, thereby improving sleep quality and reducing symptoms. Understanding these mechanisms is crucial for tailoring treatment plans to individual needs, potentially improving outcomes and quality of life for PTSD patients.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,758 Previous Clinical Trials
2,166,210 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,207 Total Patients Enrolled
Kerrie Moreau, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus
3 Previous Clinical Trials
579 Total Patients Enrolled

Media Library

NightWare (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05365607 — N/A
Post-Traumatic Stress Disorder Research Study Groups: Sham NightWare, NightWare
NightWare (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05365607 — N/A
Post-Traumatic Stress Disorder Clinical Trial 2023: NightWare Highlights & Side Effects. Trial Name: NCT05365607 — N/A
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT05365607 — N/A
~16 spots leftby Jul 2025