Sleep Duration and Cardiovascular Health

NCT04804124 | Recruiting

• 1 other identifier: 00021448
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Cardiovascular Risk Factor

Keywords

cardiovascular; sleep duration; vascular endothelial function

Outcome Measures

Primary Outcomes (20)

• Vascular Endothelial Function

  Investigators will measure endothelial function as flow-mediated dilation.

  2 weeks

• Cardiovascular Risk

  Investigators will measure cardiovascular risk as carotid intima-media thickness (IMT).

  2 weeks

• Coronary Atherosclerotic Burden

  Investigators may measure coronary atherosclerotic measure from a computerized tomography (CT) scan. This measure is optional for participants. The scan will be used to calculate coronary artery calcium score (CAC score and/or Agatston score). The CAC score indicates risk of future coronary artery events. A CAC score of 0 indicates absence of coronary artery calcification. A score of 0 is very low risk, and risk increases with increasing numbers (e.g. 100-300 is increased risk, \>300 is very high risk). Higher scores may indicate higher risk of future coronary events. The Agatston score is also an atherosclerotic measure that may indicate risk of future coronary artery events. Agatston also goes up from 1 on a linear scale (e.g. 1-100 is discreet atherosclerosis, up to 400 is moderate, \>400 is severe).

  2 weeks

• Heart rate

  Heart rate will be measured as beats per minute while participants are in a supine position.

  2 weeks

• Blood pressure

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

  2 weeks

• 24-hour BP measurement

  Investigators will measure 24-hour ambulatory blood pressure (AMBP, Spacelabs, Inc) for 24-h period before each in-lab visit, including the optional visit. Both systolic and diastolic blood pressure will be measured.

  2 weeks

• Sleep duration

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

  2 weeks

• Sleep efficiency

  Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary. Sleep efficiency measures amount of time asleep while in bed. This is measured from 0-100%, where 0 indicates low sleep efficiency, or no sleep in bed, and higher percent indicates more sleep, or higher sleep efficiency while in bed.

  2 weeks

• Physical Activity

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

  2 weeks

• Total Mood Disturbance

  Total Mood Disturbance will be measured from the Profile of Mood States (POMS) questionnaire. Participants will rate their mood states on a likert scale of 0-4. POMS may indicate both positive and negative moods. There is a minimum score of 0, and maximum of 260. In general, lower scores indicate less mood disturbance, while higher scores indicate higher mood disturbance. Subsets of particular scores may indicate particular mood states.

  2 weeks

• Timing of caloric intake

  Timing of caloric intake may be measured by participant completion of a 7-day photographic food diary before the in-lab visits. MealLoggerTM(Wellness Foundry, New York, http://www.meallogger.com). Photographs are time stamped, indicating timing of caloric intake.

  2 weeks

• Content of caloric intake

  Content of caloric intake may be measured by participant completion of a 7-day photographic food diary before the in-lab visits. MealLoggerTM(Wellness Foundry, New York, http://www.meallogger.com) These photographs may be assessed to identify micronutrients and macronutrients in content of food.

  2 weeks

• Blood Cholesterol

  Blood cholesterol (measured in plasma according to laboratory values) may be measured by a complete blood count after blood draw. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• Blood fasting glucose

  Blood fasting glucose (measured in plasma according to laboratory values) may be measured by a complete blood count after blood draw. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• C-reactive protein

  C-reactive protein (measured in plasma according to laboratory values) may be measured by lab tests after blood draw as a blood inflammatory marker. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• Interleukins

  Interleukin 6 (IL-6), Interleukin 1(IL-1 β), interleukin-1 receptor antagonist (IL-1RA), interleukin 18 (IL-18), measured in plasma according to laboratory values, may be measured by lab tests after blood draw as blood inflammatory markers. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• Plasminogen activator inhibitor-1

  Plasminogen activator inhibitor-1 (measured in plasma according to laboratory values) may be measured by lab tests after blood draw as a blood inflammatory marker. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• P-selectin

  P-selectin (measured in plasma according to laboratory values) may be measured by lab tests after blood draw as a blood inflammatory marker. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• Blood cortisol

  Cortisol (measured in plasma according to laboratory values) may be measured by lab tests after blood draw as a measure of stress. This is a hypothesis generating variable. Higher values may indicate increased cardiovascular risk.

  2 weeks

• Body Mass Index (BMI)

  Weight and height will be combined to report BMI in kg/m\^2.

  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

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.

Average Duration Sleepers; Long Sleepers; Short Sleepers

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

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

5034942064; burkeni@ohsu.edu

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: March 15, 2026
• Study Completion: March 15, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)