Stress, Sleep and Cardiovascular Risk
1 other identifier
interventional
168
1 country
1
Brief Summary
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 28, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2021
CompletedApril 4, 2018
March 1, 2018
4.1 years
March 28, 2018
March 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sleep efficiency
percent of time in bed spent asleep
6 months
Secondary Outcomes (2)
normalized high frequency ratio of heart rate variability while in bed
6 months
pulse wave velocity
6 months
Study Arms (2)
personalized behavioral recommendations
EXPERIMENTALWill receive recommendations for altering sleep related behavior based on data from in-home monitoring.
educational control
NO INTERVENTIONWill receive the data without recommendations. Will receive personalized recommendations after the follow up assessment.
Interventions
Personalized feedback and recommendations based on study observations of sleep behavior and how participants cope with potentially sleep disruptive cognitions on their frequency and impact and on sleep efficiency. A written report is provided to participants and their initial modifications are monitored.
Eligibility Criteria
You may not qualify if:
- current medical or psychiatric condition that affects sleep or requires daily - use of medication other than PTSD, phobic disorders, or past history of major depression
- severe alcohol or drug use disorders
- overnight shift worker or an extreme chronotype
- sleep disorder other than insomnia or nightmares
- morbid obesity (body mass index \> 40)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Research Unit; Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2018
First Posted
April 4, 2018
Study Start
October 1, 2017
Primary Completion
October 31, 2021
Study Completion
October 31, 2021
Last Updated
April 4, 2018
Record last verified: 2018-03