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Stress, Sleep and Cardiovascular Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03487991
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Howard University

Tracking Information
First Submitted Date  ICMJE March 28, 2018
First Posted Date  ICMJE April 4, 2018
Last Update Posted Date April 4, 2018
Actual Study Start Date  ICMJE October 1, 2017
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
sleep efficiency [ Time Frame: 6 months ]
percent of time in bed spent asleep
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2018)
  • normalized high frequency ratio of heart rate variability while in bed [ Time Frame: 6 months ]
    an index of parasympathetic nervous system activity
  • pulse wave velocity [ Time Frame: 6 months ]
    a measure of arterial elasticity
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Stress, Sleep and Cardiovascular Risk
Official Title  ICMJE Stress, Sleep and Cardiovascular Risk
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.
Detailed Description

The study has 3 specific aims.

Aim 1. To confirm the effects of neighborhood and posttraumatic stress, and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers.

Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence, and nocturnal/evening urinary noradrenergic excretion ratios.

Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time, and strategies for coping with sleep disruptive thoughts.

Aim 2. To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction.

Hypothesis 2 - Indicators of nocturnal autonomic balance will correlate with morning levels of pro-inflammatory cytokines and adhesion molecules; and pulse wave velocity.

Aim 3. To determine if sleep is improved 6 months after receiving personalized recommendations for adaptively modifying sleep-related behaviors, and if improved sleep and reduced pre-sleep cognitive arousal are associated with more favorable nocturnal autonomic balance and endothelial function.

Hypothesis 3a - Reduced frequency and intensity of sleep disruptive cognitions and improved sleep efficiency will be more likely in the group that received personalized feedback and recommendations for sleep.

Hypothesis 3b - Reduction of disruptive pre-sleep cognitions, and increased sleep efficiency will be associated with improved autonomic status at night and a more favorable profile of cardiovascular risk biomarkers.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Posttraumatic Stress Disorder
  • Insomnia
Intervention  ICMJE Behavioral: Personalized sleep intervention
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.
Study Arms  ICMJE
  • Experimental: personalized behavioral recommendations
    Will receive recommendations for altering sleep related behavior based on data from in-home monitoring.
    Intervention: Behavioral: Personalized sleep intervention
  • No Intervention: educational control
    Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 28, 2018)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2021
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:1. Healthy adults age 18 - 35, self-identified as Black or African American, born in the United States.

Exclusion Criteria:

  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Travan Hurst, BA 202-865-7267
Contact: Obisesan Yejide, BA 202-806-7818
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03487991
Other Study ID Numbers  ICMJE 1R01HL136626-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Howard University
Study Sponsor  ICMJE Howard University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Howard University
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP