Sleep Regularity and Heart Health Study
This study is looking at how keeping a regular sleep schedule affects your heart and overall health. Researchers want to see if maintaining a consistent sleep onset time (going to bed around the same time each night, within 30 minutes) for 12 weeks can improve markers related to your heart and blood vessels. They will measure changes in your dim-light melatonin onset (a marker of your body's internal clock), something called SRI, and how well your blood vessels are working. The study is for healthy men and women aged 18 to 50, and also includes a group of people with chronic pain (fibromyalgia). The goal is to understand if better sleep regularity leads to better health.
- Study design
- This is an interventional study with 30 participants. It is a 12-week prospective cohort study.
- What's involved
- You would be asked to maintain a consistent sleep onset time (within 30 minutes of your chosen time) for 12 weeks. Data collection will involve both field and in-laboratory measurements.
- Compensation
- Not stated in the trial record.
- Follow-up
- Measurements will be taken at the beginning of the study (Week 0) and at the end (Week 12).
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Influence of Sleep on Cardiovascular Outcomes
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Andrew W McHill, PhD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Changes in dim-light melatonin onsetWeek 0 and Week 12
Saliva samples will be collected pre- and post-12-week intervention and will be assayed for melatonin using standardized assays. Dim-light melatonin onset will be calculated using the linear interpolated point in time in which each participant's melatonin crosses and remains elevated above a 4pg/mL threshold. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in SRIWeek 0 and Week 12
SRI will be calculated from 2-weeks actigraphy data prior to the first in-laboratory visit. Changes in SRI will be measured for 2-weeks during Weeks 1-2, Weeks 6-7, and Weeks 11-12 for the intervention group and during Weeks 11-12 for the control group. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in vascular endothelial functionWeek 0 and Week 12
Vascular endothelial function will be assessed via flow mediated dilation pre- and post-12-week intervention. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in heart rateWeek 0 and Week 12
Heart rate will be measured every \~30 minutes via a blood pressure cuff. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in blood pressureWeek 0 and Week 12
Changes in resting blood pressure will be measured every \~30 minutes via ambulatory blood pressure machines for up to 48-hours during Weeks 1-2, Weeks 6-7, and Weeks 11-12 for the intervention group and Weeks 11-12 for the control group. Blood pressure patterns during the day and night will be assessed, as well as a contrast of day and nighttime blood pressure levels. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in resting cardiac vagal toneWeek 0 and Week 12
High frequency power of the heart rate variability power spectrum will be used to estimate cardiac parasympathetic activity (vagal tone). These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in heart rate response to exerciseWeek 0 and Week 12
Beat by beat heart rate will be recorded during a Monark bicycle ergometer exercise test where workload will be increased every 3-min until \~75% age predicted heart rate max is achieved. Heart rate will be averaged at rest, during each 3-min stage, and each minute during a 2-minute recovery. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in blood pressure response to exerciseWeek 0 and Week 12
Beat by beat blood pressure will be recorded during a Monark bicycle ergometer exercise test. Blood pressure will be averaged at rest, during each 3-min stage, and each minute during a 2-minute recovery. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in energy metabolismWeek 0 and Week 12
Resting energy expenditure and macronutrient oxidation will be measured via indirect calorimetry. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.
- Changes in glucoseWeek 0 and Week 12
Changes in glucose will be measures during Weeks 1-2, Weeks 6-7, and Weeks 11-12 for the intervention group and Weeks 11-12 for the control group. These data will be used to calculate mean differences and standard deviations between the control and intervention group for future experiments. Examined using planned comparison dependent t-tests to compare the changes pre- and post-12-weeks.