Recruiting

Cardiovascular Risk

Sponsor:

Howard University

Code:

NCT03487991

Conditions

Posttraumatic Stress Disorder

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Personalized sleep intervention

Study Details

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.

Conditions

Posttraumatic Stress Disorder

Insomnia

Study ID

NCT03487991

Start date

Oct 1, 2017

Status verified date

Mar, 2018

Completion date

Oct 31, 2021

Anticipated

Primary completion date

Oct 31, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: personalized behavioral recommendations

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

no intervention: educational control

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

Interventions

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.

Primary outcome measure

  • sleep efficiency [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Travan Hurst, BA

202-865-7267TLHurst@Howard.edu

Obisesan Yejide, BA

202-806-7818Yejide.Obisesan@Howard.edu

Locations

Clinical Research Unit; Howard University Hospital

Recruiting

Washington, District of Columbia, United States, 20060

Contacts

Alice Ukaegbu, DMP MSN

202-865-7276aukaegbu@howard.edu

Obisesan Yejide, BA

202-806-7818yejide.obisesan@howard.edu

Principal Investigator:

Thomas A Mellman, M.D.

More Information

Sponsor

Howard University

Last update posted

Apr 4, 2018

Last verified

Mar, 2018

Keywords

  • autonomic balance
  • sleep
  • endothelial function
  • behavior
  • stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Howard University on 2018-04-04.