Actively Recruiting
Determining the Influence of Sleep on Cardiovascular Outcomes
Led by Oregon Health and Science University · Updated on 2025-11-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
M
Medical Research Foundation, Oregon
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how consistent sleep patterns affect cardiovascular and metabolic health in healthy adults aged 18 to 40 years. The study aims to understand if improving the regularity of sleep timing can positively influence heart, blood vessel, and metabolic functions. A subgroup with chronic pain will also be studied to assess the impact of sleep regularity on pain outcomes. Participants in the lowest third for sleep regularity will follow a 12-week intervention maintaining a consistent sleep onset time within 30 minutes of their chosen bedtime. The control group will continue their usual sleep patterns. Data collection includes two weeks of sleep monitoring using actigraphy and sleep logs, in-laboratory visits for circadian and vascular assessments, blood draws for biomarker analysis, and ambulatory monitoring with blood pressure cuffs and continuous glucose monitors. Participants will attend baseline and 12-week laboratory visits for blood samples and health measurements. Throughout the study, they will complete daily surveys and wear devices to track sleep and cardiovascular data. Researchers will measure changes in melatonin levels, sleep regularity, heart rate, blood pressure, metabolic markers, body composition, and pain severity. The study duration is approximately 12 weeks, with multiple assessments to evaluate the effects of sleep regularity on health.
CONDITIONS
Brief Title
The Influence of Sleep on Cardiovascular Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ostensibly healthy men and women aged 18 to 50 years
- Participants meeting fibromyalgia diagnostic criteria for the chronic pain subgroup
- Symptoms present at a similar level for at least 3 months for chronic pain subgroup
- No other disorder explaining the pain for chronic pain subgroup
You will not qualify if you...
- History of drug or alcohol dependency
- Current smokers or history of more than 5 pack years of smoking
- History of irregular day/night work, regular night shifts, or rotating shift work in the past year
- Travel across more than one time zone in the past 3 months
- Diagnosed chronobiologic or sleep disorders
- Cardiovascular diseases beyond normotensive or uncomplicated stage 1 hypertension
- Respiratory system disorders
- Self-reported pre-diabetes or diabetes
- Kidney and urinary tract disorders
- Infectious diseases
- Gastrointestinal disorders
- Immune system disorders
- Hematopoietic system disorders
- Neoplastic diseases
- Endocrine and metabolic diseases
- Neurologic disorders
- Participation in another research study that affects safe participation in this study
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants wear an actigraphy device and keep sleep logs to assess habitual sleep patterns and calculate a sleep regularity index over 2 weeks.
Wearing devices and keeping logs during this period
Duration - Baseline and Week 12
Participants attend two in-laboratory visits involving overnight stays to measure circadian markers, body composition, vascular function, and collect saliva and blood samples.
2 visits (in-person) including overnight stays
Duration - Approximately 12 weeks
Participants in the intervention group maintain a consistent sleep onset time (±30 min) for approximately 12 weeks while control participants maintain habitual sleep patterns.
Ongoing adherence monitored via sleep logs, actigraphy, and daily surveys during specified periods
Duration - Multiple 2-week periods within the 12-week intervention
Participants wear actigraphy devices, ambulatory blood pressure cuffs, and continuous glucose monitors while completing daily surveys during biobehavioral data collection periods.
1 to 3 periods of 2-week monitoring depending on group assignment
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
A
Andrew W McHill, PhD
B
Brooke M Shafer
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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