NCT04804124

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Jun 2021Sep 2027

First Submitted

Initial submission to the registry

March 10, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 18, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

6.3 years

First QC Date

March 10, 2021

Last Update Submit

July 31, 2026

Conditions

Keywords

cardiovascularsleep durationvascular endothelial function

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Short Sleepers

EXPERIMENTAL

Reported nightly sleep time of ≤6 hours

Behavioral: Regularized Sleep Schedule

Long Sleepers

EXPERIMENTAL

Reported nightly sleep time of ≥9 hours

Behavioral: Regularized Sleep Schedule

Average Duration Sleepers

EXPERIMENTAL

Reported nightly sleep time of 7-8 hours

Behavioral: Regularized Sleep Schedule

Interventions

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 SleepersLong SleepersShort Sleepers

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Study Officials

  • Saurabh S Thosar, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Chaudhary, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 10, 2021

First Posted

March 18, 2021

Study Start

June 9, 2021

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

September 15, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations