Determining the Influence of Sleep on Cardiovascular Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: t
View:

• 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.

Locations
United States
Oregon
Oregon Health & Science University
RECRUITING
Portland
Contact Information
Primary
Andrew W McHill, PhD
mchill@ohsu.edu
(503) 494 - 2594
Backup
Brooke M Shafer
shaferb@ohsu.edu
(503) 494 - 0670
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 30
Treatments
Experimental: Sleep Regularity Group
Individuals in the lowest SRI tertile will begin the 12-week intervention to improve sleep regularity. Participants will be instructed to maintain a consistent sleep onset time (±30 min self-selected sleep time).
No_intervention: Control Group
All other participants will be instructed to maintain their habitual sleep patterns.
Related Therapeutic Areas
Sponsors
Collaborators: Medical Research Foundation, Oregon
Leads: Oregon Health and Science University

This content was sourced from clinicaltrials.gov