Status:
RECRUITING
The Influence of Sleep on Cardiovascular Outcomes
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
Medical Research Foundation, Oregon
Conditions:
Circadian Rhythm
Cardiometabolic Health
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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...
Detailed Description
Sleep is a fundamental determinant of heath; however, the impact of day-to-day variations in sleep patterns (i.e., sleep regularity) on cardiometabolic and vascular health has been underappreciated. E...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06535178
Start Date
July 1 2024
End Date
September 30 2026
Last Update
November 7 2025
Active Locations (1)
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1
Oregon Health & Science University
Portland, Oregon, United States, 97239