Sleep Duration and Cardiovascular Health

NCT ID: NCT04804124

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-09
• Study Completion Date: 2026-03-15

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.

Conditions

Sleep; Cardiovascular Risk Factor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Short Sleepers

Reported nightly sleep time of ≤6 hours

Group Type: EXPERIMENTAL

Regularized Sleep Schedule

Intervention Type: BEHAVIORAL

Participants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention.

Long Sleepers

Reported nightly sleep time of ≥9 hours

Group Type: EXPERIMENTAL

Regularized Sleep Schedule

Intervention Type: BEHAVIORAL

Participants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention.

Average Duration Sleepers

Reported nightly sleep time of 7-8 hours

Group Type: EXPERIMENTAL

Regularized Sleep Schedule

Intervention Type: BEHAVIORAL

Participants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention.

Interventions

Regularized Sleep Schedule

Participants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Saurabh Thosar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saurabh S Thosar, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Oregon Health and Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nicole Chaudhary, MPH

Role: CONTACT

burkeni@ohsu.edu

5034942064

Facility Contacts

Saurabh S Thosar, PhD

Role: primary

clinphys@ohsu.edu

503-494-2064

Other Identifiers

00021448

Identifier Type: -

Identifier Source: org_study_id