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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured before and after 6 weeks of nightware and sham conditions
Awards & highlights

Study 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
Select...
I often have nightmares that disturb my sleep.

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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,642 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,658 Previous Clinical Trials
28,004,449 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this clinical trial?

"Affirmative. Clinicaltrials.gov affirms that this trial is actively enrolling participants, having been first published on June 24th 2022 and most recently updated on August 12th 2022. To date, 50 people have registered to take part at two different sites."

Answered by AI

Are senior citizens included in the parameters of this research endeavor?

"Based on the trial's criteria for patient enrollment, those aged between 22 and 99 years of age are eligible to participate."

Answered by AI

Are there any vacancies left for enrollees in this trial?

"According to clinicaltrials.gov, this study is currently recruiting patients with the trial having been posted on June 24th 2022 and last updated on August 12th of that same year."

Answered by AI

Could I potentially become a participant in this research?

"For this medical experiment, 50 individuals afflicted with PTSD aged between 22 and 99 will be accepted. To meet the eligibility requirements for admission, applicants must have a formal diagnosis of Post Traumatic Stress Disorder matching that detailed in Diagnostic and Statistical Manual of Mental Disorders' (DSM-5) fifth edition; recurrent nightmares affecting sleep quality; blood pressure lower than 160/100 mmHg while at rest; fasted glucose level below 126 mg/dL; no smoking history or use of dietary supplements or anti-inflammatory medications one month preceding enrollment into trial; Pittsburgh Sleep Quality Index scores above 6 and Epworth Sleepiness Scale results higher than 0"

Answered by AI

Who else is applying?

What state do they live in?
Colorado
What site did they apply to?
University of Colorado Anschutz Medical Campus
University of Colorado CCTSI CTRC
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Nightmares so bad cannot sleep,fear of sleeping.
PatientReceived 1 prior treatment
~2 spots leftby Apr 2024