Sleep Duration and Cardiovascular Health (Goldilocks)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Regularized Sleep Schedule

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicole Chaudhary, MPH; Phone Number: 5034942064; Email: burkeni@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Health and Science University
      • Contact: Saurabh S Thosar, PhD; Phone Number: 503-494-2064; Email: clinphys@ohsu.edu
      • Principal Investigator: Saurabh S Thosar, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Short Sleepers; Reported nightly sleep time of ≤6 hours	Behavioral: 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.
Experimental: Long Sleepers; Reported nightly sleep time of ≥9 hours	Behavioral: 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.
Experimental: Average Duration Sleepers; Reported nightly sleep time of 7-8 hours	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular Endothelial Function	Investigators will measure endothelial function as flow-mediated dilation.	2 weeks
Blood pressure	Blood pressure (systolic and diastolic) will be measured in a supine position in the dominant arm.	2 weeks
Sleep duration	Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.	2 weeks

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Saurabh S Thosar, PhD, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2021
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: cardiovascular; sleep duration; vascular endothelial function
• Other Study ID Numbers: 00021448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No