The Influence of Sleep on Cardiovascular Outcomes
Determining the Influence of Sleep on Cardiovascular Outcomes
Oregon Health and Science University
30 participants
Jul 1, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this study is to identify the effects of sleep regularity on cardiovascular regulatory mechanisms. The investigators are hoping to discover if improving the regularity of sleep timing will improve metabolic and vascular health markers. The protocol is a 12-week prospective cohort study that includes both field and in-laboratory data collection in ostensibly healthy male and female adults, aged 18-40years. We will also have a sub-group of individuals with chronic pain to examine the effects of sleep regularity on pain outcomes.
Eligibility
Inclusion Criteria5
- Ostensibly healthy men and women Subgroup study (chronic pain)
- Satisfies diagnostic criteria for fibromyalgia according to the Widespread Pain Index - Symptom Severity (WPI-SS) scale with the following three conditions being met:
- Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9.
- Symptoms have been present at a similar level for at least 3 months.
- The patient does not have a disorder that would otherwise explain the pain.
Exclusion Criteria17
- No history of drug or alcohol dependency.
- Must be current non-smokers, and are required to have a history of less than 5 pack years of smoking.
- No history of working irregular day and night hours, regular night work, or rotating shift work for the 1 year prior to the study. In addition to this, individuals must not have traveled across more than 1 time zone during the 3 months prior to the study.
- Chronobiologic and sleep disorders.
- Diseases of the cardiovascular system.
- Hypertension. Individuals will be allowed to be normotensive (resting systolic blood pressure of <140/90 mmHg, measured on more than one occasion) or uncomplicated stage 1 hypertension (systolic BP between 140 and 159 mmHg or a diastolic BP between 90 and 99 mmHg).
- Disorders of the respiratory system.
- Pre-diabetes/Diabetes. For participants who have self-reported pre-diabetes/diabetes.
- Disorders of the kidney and urinary tract.
- Infectious diseases.
- Disorders of the gastrointestinal system.
- Disorders of the immune system.
- Disorders of the hematopoietic system.
- Neoplastic diseases.
- Endocrine and metabolic diseases.
- Neurologic disorders.
- Must not be participating in another research study that would influence their safe participation in the study.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Maintained consistent sleep onset time (±30 min self-selected sleep time) for 12-weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06535178