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Stress, Sleep and Cardiovascular Risk

Stress, Sleep and Cardiovascular Risk

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03487991
Enrollment
168
Registered
2018-04-04
Start date
2017-10-01
Completion date
2021-10-31
Last updated
2018-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Posttraumatic Stress Disorder

Keywords

autonomic balance, sleep, endothelial function, behavior, stress

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.

Interventions

BEHAVIORALPersonalized 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.

Sponsors

Howard University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
sleep efficiency6 monthspercent of time in bed spent asleep

Secondary

MeasureTime frameDescription
normalized high frequency ratio of heart rate variability while in bed6 monthsan index of parasympathetic nervous system activity
pulse wave velocity6 monthsa measure of arterial elasticity

Countries

United States

Contacts

Primary ContactTravan Hurst, BA
TLHurst@Howard.edu202-865-7267
Backup ContactObisesan Yejide, BA
Yejide.Obisesan@Howard.edu202-806-7818

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026