Effects of Sleep Regularity on Heart and Metabolic Health

Determining the Influence of Sleep on Cardiovascular Outcomes

This study is testing if sticking to a regular sleep schedule can improve heart and metabolic health in healthy adults aged 18 to 40.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Oregon Health and Science University (other)
• Locations: 1 site (Portland, Oregon)
• Trial ID: NCT06535178 on ClinicalTrials.gov

What this trial studies

This study aims to explore how consistent sleep patterns influence cardiovascular and metabolic health in healthy adults aged 18-40. Over a 12-week period, participants with irregular sleep will follow a strict sleep schedule to assess changes in health markers. The research will involve both field and laboratory data collection to evaluate the impact of sleep regularity on cardiometabolic and vascular functions. The findings could provide insights into the relationship between sleep habits and overall health.

Who should consider this trial

Good fit: Ideal candidates are healthy men and women aged 18-40 who experience irregular sleep patterns.

Not a fit: Patients with cardiovascular diseases, chronic sleep disorders, or significant smoking history may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved cardiovascular and metabolic health outcomes through better sleep management.

How similar studies have performed: Other studies have indicated a correlation between sleep regularity and health outcomes, suggesting potential for success in this approach.

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.

Where this trial is running

Portland, Oregon

• Oregon Health & Science University — Portland, Oregon, United States (RECRUITING)

Study contacts

• Principal investigator: Andrew W McHill, PhD — Oregon Health and Science University
• Study coordinator: Andrew W McHill, PhD

Conditions: Circadian Rhythm, Cardiometabolic Health, Vascular Health, Pain