American Health and Science University started a clinical trial of Sleep Duration and Cardiovascular Health
Oregon Health and Science University is enrolling patients into the clinical trial investigating Sleep Duration and Cardiovascular Health (Goldilocks).
This is a 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.
The investigators have 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.
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.
The trial is designed to enroll male and female 25 to 65 years and is being conducted in the Oregon Health and Science University, Portland, Oregon, United States.
The study start date is March 15, 2021.
The patients that can be enrolled into this study include:
- Men and women ages 25-65 years
- 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.
This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04804124
