NCT06535178 The Influence of Sleep on Cardiovascular Outcomes
| NCT ID | NCT06535178 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Circadian Rhythm |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2024-07-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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 Criteria
Inclusion Criteria: * 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: 1. Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9. 2. Symptoms have been present at a similar level for at least 3 months. 3. The patient does not have a disorder that would otherwise explain the pain. Exclusion Criteria: * 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.
Contact & Investigator
Andrew W McHill, PhD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT06535178 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Circadian Rhythm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06535178 currently recruiting?
Yes, NCT06535178 is actively recruiting participants. Contact the research team at mchill@ohsu.edu for enrollment information.
Where is the NCT06535178 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06535178 clinical trial?
NCT06535178 is sponsored by Oregon Health and Science University. The principal investigator is Andrew W McHill, PhD at Oregon Health and Science University. The trial plans to enroll 30 participants.