Frontlight ResearchEarly access
CompletedNo phase
NightWare and Cardiovascular Health in Adults With PTSD
Key facts
- Who runs it
- University of Colorado, Denver
- Where
- Aurora and Denver, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 40 people enrolled
- Started
- 24 Jun 2022
- Ended
- 18 Aug 2024
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- NightWare
- Sham NightWare
- Record updated
- 8 October 2024
Who can take part
- Age
- 22 years to 99 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- Diagnosis of PTSD via American Psychiatric Association PTSD diagnostic criteria in the fifth edition of its Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- Self-report having repetitive nightmares contributing to disrupted sleep
- age >22 years (rationale is because the device has only been used in adults in 22 years and older)
- resting blood pressure (BP, <160/100 mmHg)
- fasted glucose <126 mg/d
- non-smokers
- no use of vitamin supplements or anti-inflammatory medications, or willing to stop 1 month prior to the vascular visit
- Pittsburgh Sleep Quality Index (PSQI) score 6 or higher
- Epworth Sleepiness Scale (ESS): Question #8 score above "0" will prompt an additional question: Does individual drive ("get behind the wheel") when they are drowsy? The answer must be "No" to be enrolled in the study due to safety concerns
- Wireless Internet and two power outlets where they sleep
- Willingness not to use any other application which collects heart rate data on the phone and watch that is used for NightWare
Who cannot take part
- current use (or within previous 6 months) of hormone therapy in postmenopausal women
- Prazosin use; however, participant may be included if tapered by prescribing provider. Taper must be completed and individual must be off prazosin for 2 days prior to enrollment
- Acting out of dreams prior to PTSD trauma; 17) Diagnosis or suspicion of dementia
- uncontrolled hypertension
- current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection
- diabetes
- current substance (including marijuana) or alcohol use disorder (past 12 months) per the SCID-5 (see methods of Research Strategy). Adults with past substance or alcohol use disorders will be allowed to participate
- thyroid dysfunction, defined as an ultrasensitive TSH <0.5 or >5.0 mU/L; volunteers with abnormal TSH values will be re-considered for participation in the study after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement; or other problems that would interfere with participation in the study
- pregnancy or currently breast feeding
- 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])
- Current use of varenicline, beta-blockers (unless ophthalmic solutions), or non-dihydropyridines
- Shift workers (due to circadian rhythm disruption)
- Moderate or Severe obstructive sleep apnea (either diagnosed or determined during screening with the WatchPat [AHI≥15]
- Diagnosis of narcolepsy
- Known sleepwalking
Where in United States
- University of Colorado Anschutz Medical CampusAurora, United States
- University of Colorado CCTSI CTRCDenver, United States
About the trial
What the trial wants to find out
The purpose of this study is to determine whether NightWare therapeutic intervention improves biomarkers of vascular aging and autonomic function in adults with nightmares related to PTSD.
The 2 groups in the trial
- NightWareTreatment being tested
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.
- Sham NightWareSham treatment, for comparison
In individuals randomized to the sham condition, the NightWare intervention will not be enabled.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- NightWare Therapeutic Platform for Improving Cardiovascular Health in Adults With Nightmares Associated With PTSD
- Record updated
- 8 October 2024