NightWare and Cardiovascular Health in Adults With PTSD

NCT05365607 | Completed DMC FDA Device

• 2 other identifiers: 21-5027R21AG075544
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Posttraumatic Stress Disorder; Cardiovascular Diseases; Autonomic Dysfunction; Vascular Stiffness; Nightmare; Endothelial Dysfunction

Keywords

sleep; oxidative stress; aging; inflammation; sex/gender

Outcome Measures

Primary Outcomes (3)

• Change in large elastic artery stiffness -carotid artery

  Carotid artery compliance using carotid artery ultrasound

  Measured before and after 6 weeks of NightWare and sham conditions

• Change in endothelial function

  Brachial artery flow-mediated dilation (FMD) using ultrasound

  Measured before and after 6 weeks of NightWare and sham conditions

• Change in 1utonomic function - BRS

  Cardiovagal baroreflex sensitivity (cBRS)

  Measured before and after 6 weeks of NightWare and sham conditions

Secondary Outcomes (2)

• Change in large elastic artery stiffness

  Measured before and after 6 weeks of NightWare and sham conditions

• Change in autonomic function - HRV

  Measured before and after 6 weeks of NightWare and sham conditions

Other Outcomes (13)

• Change in PSQI

  Measured before and after 6 weeks of NightWare and sham conditions

• Change in PSQI-A

  Measured before and after 6 weeks of NightWare and sham conditions

• Change in Epworth sleepiness scale (ESS)

  Measured before and after 6 weeks of NightWare and sham conditions

Study Arms (2)

NightWare

EXPERIMENTAL

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.

Device: NightWare

Sham NightWare

SHAM COMPARATOR

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

Device: Sham NightWare

Interventions

NightWare DEVICE

A wearable digital therapeutic platform consisting of an Apple Watch and iPhone pre-provisioned with Nightware intervention app that will deliver a mild vibration to the watch after detecting individual having a nightmare based on Nightware proprietary algorithm, arousing the individual and disrupting nightmare without awakening.

NightWare

Sham NightWare DEVICE

NightWare device will not deliver an intervention (i.e., no vibration)

Sham NightWare

Eligibility Criteria

• Age: 22 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• uncontrolled hypertension;
• current or preexisting CVD or cancers (with the exception of past skin cancers) or active infection;
• diabetes;
• 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;
• current use (or within previous 6 months) of hormone therapy in postmenopausal women;
• 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.
• 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;
• 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;
• \) Acting out of dreams prior to PTSD trauma; 17) Diagnosis or suspicion of dementia

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

University of Colorado CCTSI CTRC

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cardiovascular Diseases; Primary Dysautonomias; Inflammation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Autonomic Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kerrie Moreau, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo (i.e., sham intervention) controlled parallel pilot study

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: May 9, 2022
• Study Start: June 24, 2022
• Primary Completion: August 15, 2024
• Study Completion: August 18, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)