Sleep Duration and Cardiovascular Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Regularized Sleep Schedule.
- Who it may be relevant to
- Registry conditions: Sleep, Cardiovascular Risk Factor. Basic parameters: 25 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed 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.
Interventions
- Behavioral Regularized Sleep Schedule
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.
Primary outcome measures
- Vascular Endothelial Function [Time frame: 2 weeks]
- Blood pressure [Time frame: 2 weeks]
- Sleep duration [Time frame: 2 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Oregon Health and Science University — Portland
Identifiers
NCT: NCT04804124 · 00021448