Sleep Duration and Cardiovascular Health (Goldilocks)

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Cardiovascular Risk Factor; Sleep

Treatments: Behavioral: Regularized Sleep Schedule

Study type: Interventional

Funder types: Other

Identifiers

NCT04804124

00021448

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Short Sleepers

Experimental group

Description:

Reported nightly sleep time of ≤6 hours

Treatment:

Behavioral: Regularized Sleep Schedule

Long Sleepers

Experimental group

Description:

Reported nightly sleep time of ≥9 hours

Treatment:

Behavioral: Regularized Sleep Schedule

Average Duration Sleepers

Experimental group

Description:

Reported nightly sleep time of 7-8 hours

Treatment:

Behavioral: Regularized Sleep Schedule