Clinical trial NCT04804124: Sleep Duration and Cardiovascular Health
Official title: Sleep Duration and Cardiovascular Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Cardiovascular Risk Factor
Keywords: cardiovascular
sleep duration
vascular endothelial function
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a cross-sectional study with an optional intervention that will examine how extreme sleep durations relate to cardiovascular health, physical activity, and sleep quality by studying three groups of participants: short sleepers (≤ 6 hrs), long sleepers (≥ 9 hrs), and average duration sleepers (7-8 hrs). The optional intervention asks participants to maintain an 8-hour per night regular sleep schedule for one week.

Detailed description: PRIMARY OBJECTIVES:

1. To test the hypothesis that vascular endothelial function in the brachial artery, and other associated cardiovascular risk markers are impaired in short sleepers and long sleepers as compared to the control group of average duration sleepers.

To test the hypothesis that the optional intervention to maintain an 8-hour per night sleep schedule will alleviate vascular endothelial function impairment.

OUTLINE:

Participants will measure sleep, physical activity, and blood pressure with at-home devices before coming in for one in-lab visit, where they will have vascular function and blood markers measured, as well as an optional CT scan to measure calcium in the coronary arteries. An optional intervention may occur after this: Participants will continue the at-home measures while maintaining a chosen regular 8-hour per night sleep schedule, before coming in for a second in-lab visit with all same measures except for CT scan.

Eligibility criteria: Inclusion Criteria:

* Men and women ages 25-65y
* Lean and overweight (BMI 18.5-40 kg/m2)
* No acute, chronic, or debilitating medical conditions
* No prescription/non-prescription medications or drugs of abuse
* Current non-smoker (tobacco and marijuana)
* Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, and additional sleep and health profiling questionnaires may be eligible to participate.

Exclusion Criteria:

* Persons with any acute, chronic, or debilitating medical condition except pre-hypertension will be excluded.
* Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded.
* Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded.
* Persons with a history of regular night/or rotating shift work in the past year, or who have traveled more than three time zones during the one month prior to the study will be excluded.
* Pregnant women, decisionally impaired adults, and prisoners will be excluded.

Primary outcomes:
measure: Vascular Endothelial Function
timeFrame: 2 weeks
measure: Cardiovascular Risk
timeFrame: 2 weeks
measure: Coronary Atherosclerotic Burden
timeFrame: 2 weeks
measure: Heart rate
timeFrame: 2 weeks
measure: Blood pressure
timeFrame: 2 weeks
measure: 24-hour BP measurement
timeFrame: 2 weeks
measure: Sleep duration
timeFrame: 2 weeks
measure: Sleep efficiency
timeFrame: 2 weeks
measure: Physical Activity
timeFrame: 2 weeks
measure: Total Mood Disturbance
timeFrame: 2 weeks
measure: Timing of caloric intake
timeFrame: 2 weeks
measure: Content of caloric intake
timeFrame: 2 weeks
measure: Blood Cholesterol
timeFrame: 2 weeks
measure: Blood fasting glucose
timeFrame: 2 weeks
measure: C-reactive protein
timeFrame: 2 weeks
measure: Interleukins
timeFrame: 2 weeks
measure: Plasminogen activator inhibitor-1
timeFrame: 2 weeks
measure: P-selectin
timeFrame: 2 weeks
measure: Blood cortisol
timeFrame: 2 weeks
measure: Body Mass Index (BMI)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Saurabh S Thosar, PhD
role: PRINCIPAL_INVESTIGATOR
References: