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.|
|ClinicalTrials.gov Identifier: NCT03487991|
Recruitment Status : Recruiting
First Posted : April 4, 2018
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder Insomnia||Behavioral: Personalized sleep intervention||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- sleep efficiency [ Time Frame: 6 months ]percent of time in bed spent asleep
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03487991
|Contact: Travan Hurst, BA||202-865-7267||TLHurst@Howard.edu|
|Contact: Obisesan Yejide, BA||202-806-7818||Yejide.Obisesan@Howard.edu|
|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 email@example.com|
|Contact: Obisesan Yejide, BA 202-806-7818 firstname.lastname@example.org|
|Principal Investigator: Thomas A Mellman, M.D.|
|Sub-Investigator: Ihori Kobayashi, Ph.D.|