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Stress, Sleep and Cardiovascular Risk

Primary Purpose

Posttraumatic Stress Disorder, Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personalized sleep intervention
Sponsored by
Howard University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posttraumatic Stress Disorder focused on measuring autonomic balance, sleep, endothelial function, behavior, stress

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Clinical Research Unit; Howard University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

personalized behavioral recommendations

educational control

Arm Description

Will receive recommendations for altering sleep related behavior based on data from in-home monitoring.

Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment.

Outcomes

Primary Outcome Measures

sleep efficiency
percent of time in bed spent asleep

Secondary Outcome Measures

normalized high frequency ratio of heart rate variability while in bed
an index of parasympathetic nervous system activity
pulse wave velocity
a measure of arterial elasticity

Full Information

First Posted
March 28, 2018
Last Updated
March 28, 2018
Sponsor
Howard University
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1. Study Identification

Unique Protocol Identification Number
NCT03487991
Brief Title
Stress, Sleep and Cardiovascular Risk
Official Title
Stress, Sleep and Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 31, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Howard University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Insomnia
Keywords
autonomic balance, sleep, endothelial function, behavior, stress

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
personalized behavioral recommendations
Arm Type
Experimental
Arm Description
Will receive recommendations for altering sleep related behavior based on data from in-home monitoring.
Arm Title
educational control
Arm Type
No Intervention
Arm Description
Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment.
Intervention Type
Behavioral
Intervention Name(s)
Personalized sleep intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
sleep efficiency
Description
percent of time in bed spent asleep
Time Frame
6 months
Secondary Outcome Measure Information:
Title
normalized high frequency ratio of heart rate variability while in bed
Description
an index of parasympathetic nervous system activity
Time Frame
6 months
Title
pulse wave velocity
Description
a measure of arterial elasticity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Travan Hurst, BA
Phone
202-865-7267
Email
TLHurst@Howard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Obisesan Yejide, BA
Phone
202-806-7818
Email
Yejide.Obisesan@Howard.edu
Facility Information:
Facility Name
Clinical Research Unit; Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Ukaegbu, DMP MSN
Phone
202-865-7276
Email
aukaegbu@howard.edu
First Name & Middle Initial & Last Name & Degree
Obisesan Yejide, BA
Phone
202-806-7818
Email
yejide.obisesan@howard.edu
First Name & Middle Initial & Last Name & Degree
Thomas A Mellman, M.D.
First Name & Middle Initial & Last Name & Degree
Ihori Kobayashi, Ph.D.

12. IPD Sharing Statement

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Stress, Sleep and Cardiovascular Risk

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