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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

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Insomnia Behavioral: Personalized sleep intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Stress, Sleep and Cardiovascular Risk
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Arm Intervention/treatment
Experimental: personalized behavioral recommendations
Will receive recommendations for altering sleep related behavior based on data from in-home monitoring.
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.

No Intervention: educational control
Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment.

Primary Outcome Measures :
  1. sleep efficiency [ Time Frame: 6 months ]
    percent of time in bed spent asleep

Secondary Outcome Measures :
  1. normalized high frequency ratio of heart rate variability while in bed [ Time Frame: 6 months ]
    an index of parasympathetic nervous system activity

  2. pulse wave velocity [ Time Frame: 6 months ]
    a measure of arterial elasticity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03487991

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Contact: Travan Hurst, BA 202-865-7267
Contact: Obisesan Yejide, BA 202-806-7818

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United States, District of Columbia
Clinical Research Unit; Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Contact: Alice Ukaegbu, DMP MSN    202-865-7276   
Contact: Obisesan Yejide, BA    202-806-7818   
Principal Investigator: Thomas A Mellman, M.D.         
Sub-Investigator: Ihori Kobayashi, Ph.D.         
Sponsors and Collaborators
Howard University
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Responsible Party: Howard University Identifier: NCT03487991    
Other Study ID Numbers: 1R01HL136626-01 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2018    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Howard University:
autonomic balance
endothelial function
Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders