Sleep Clinical Trial
— PACEOfficial title:
Sedentary Behavior, Cardiovascular Function, and Sleep
Verified date | August 2022 |
Source | Oregon Health and Science University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an interventional study that will examine how sedentary behavior (decreased physical inactivity) over time affects cardiovascular health (i.e. heart rate and blood pressure) and sleep quality/duration.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | March 31, 2023 |
Est. primary completion date | March 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 80 Years |
Eligibility | Inclusion Criteria: - Ages 20-80y - 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 - Limited weight training or intense exercise (swimming, CrossFit) - Non-smoker - Average level of daily physical activity (8,000-12,499 steps/day) - Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, sleep profiling questionnaire, and electrocardiogram and clinical biochemical screening tests of blood and urine may be eligible to participate. Exclusion Criteria: - Persons with any acute, chronic, or debilitating medical condition except pre-hypertension and/or mild to moderate sleep apnea 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, or who have traveled more than three time zones during the one month prior to the study will be excluded. - Pregnant persons, decisionally impaired adults, and prisoners will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | Oregon Institute of Occupational Health Sciences | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Oregon Health and Science University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Endothelial Function | Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials. | 3 weeks | |
Primary | Oxidative stress | Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma. | 3 weeks | |
Primary | Endothelin-1 | Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma. | 3 weeks | |
Primary | Heart rate | During the weekly trials, heart rate will be measured as beats per minute while participants are in a seated position during the prolonged sitting period. | 3 weeks | |
Primary | Blood pressure | During the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm | 3 weeks | |
Primary | 24-hour BP measurement | Investigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit. | 3 weeks | |
Primary | Sleep duration | Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary. | 3 weeks | |
Primary | Sleep efficiency | Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary. | 3 weeks | |
Primary | Activity | Activity will be scored from the ActiGraph and correlated with the sleep and activity diary. | 3 weeks | |
Primary | Activity Perception | Activity perception will be measured before each prolonged sitting trial using an Activity Perception questionnaire (Perception of Current Activity Questionnaire). The questionnaire has 7 questions with answers ranging from 1 to 5. The range of scores is from 7 to 35, with 7 suggesting a strong negative perception of current activity, and 35 suggesting a strong positive perception of current activity. | 3 weeks |
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