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Sleep Duration and Cardiovascular Health (Goldilocks)

Oregon Health & Science University (OHSU) logo

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)

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

Trial contacts and locations

1

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Central trial contact

Nicole Chaudhary, MPH

Data sourced from clinicaltrials.gov

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