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NCT Number: NCT04804124

Sleep Duration and Cardiovascular Health

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.

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Key information

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Saurabh S Thosar, PhD

CONTACT

[email protected]

503-494-2064

Saurabh S Thosar, PhD

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVES:

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Regularized Sleep Schedule

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.

Primary outcomes

  1. Vascular Endothelial Function

    Time frame: 2 weeks

    Investigators will measure endothelial function as flow-mediated dilation.

  2. Blood pressure

    Time frame: 2 weeks

    Blood pressure (systolic and diastolic) will be measured in a supine position in the dominant arm.

  3. Sleep duration

    Time frame: 2 weeks

    Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Chaudhary, MPH

CONTACT

[email protected]

5034942064

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Acronym: Goldilocks

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2021
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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