The Influence of Sleep on Cardiovascular Outcomes (DISCO)
Determining the Influence of Sleep on Cardiovascular Outcomes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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. Emerging evidence suggests that less regularity in sleep timing is correlated with cardiometabolic health and is a stronger predictor of mortality risk than sleep duration. In this cohort, the investigators will determine the influence of sleep regularity on mechanisms that impact cardiometabolic, vascular, and autonomic function.
The misalignment of behaviors (e.g., sleep) with the internal timing system (i.e., circadian misalignment) is likely a mechanistic contributor to unfavorable health outcomes. Laboratory experiments have shown that acute circadian misalignment increases markers of inflammation, alters metabolism, and elevates mean arterial pressure. We have shown that poorer overnight blood pressure dipping patterns are associated with circadian disruptions elicited by decreased sleep regularity, which occurs within 90-days of transitioning to a shift work schedule. There is a need to characterize the influence of sleep regularity on the underlying pathways that affect health.
The goal of this study is to determine the effect of an intervention targeting improved sleep regularity on circadian, metabolic, and vascular health markers. Participants within the lowest tertile for sleep regularity will adhere to a consistent sleep onset time (±30 min) for approximately 12-weeks. The outcomes that the investigators will focus on will be indices of hemodynamics (blood pressure, heart rate, autonomic function), blood biomarkers (markers of inflammation, oxidative stress, and triglycerides), energy metabolism, weight, and percent body fat. We will also have a sub-group of individuals with chronic pain to examine the effects of sleep regularity on pain outcomes.
- Outpatient Biobehavioral Weeks: Actigraphy data will be collected across 2-weeks to assess habitual sleep patterns and calculate a sleep regularity index (SRI).
- Biobehavioral Laboratory Visit: Participants will be asked to visit the OHSU School of Nursing (SON) Biobehavioral Laboratory space for two in-laboratory visits in dim-light settings, which will involve an evening stay (~7.5h) to measure circadian markers, body composition, vascular function, and questionnaire data. Saliva samples will also be collected via salivettes in order to measure the hormone melatonin and determine each participants' dim-light melatonin onset (DLMO). Participants lowest SRI tertile (intervention group) will be instructed to maintain a consistent sleep onset time (±30 min self-selected sleep time) for up to 12-weeks. Compliance will be assessed across 6-weeks of outpatient bio-behavioral data collection via sleep logs, actigraphy, and daily surveys (described below). All other participants (control group) will be instructed to maintain their habitual sleep patterns for up to 12-weeks.
- Ambulatory Monitoring: For participants in the intervention group, biobehavioral data collection will occur at Weeks 1-2, Weeks 6-7, and Weeks 11-12. For the control group, biobehavioral data collection will occur at Weeks 11-12. During these weeks, participants will wear an actigraphy device and keep sleep logs for 2-weeks during the biobehavioral data collection. Participants will also wear an ambulatory blood pressure cuff. Additionally, to measure glucose levels throughout the protocol, participants will be fitted with a continuous glucose monitor. Participants will complete daily surveys each bio-behavioral period to measure self-reported bed and wake times and naps.
- Blood Biomarkers: At baseline and at Week 12, participants will visit the SON Biobehavioral Laboratory for a blood draw to obtain markers of inflammation, oxidative stress, and lipemic markers that will be measured with an ~10mL blood draw.
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Andrew W McHill, PhD
- Phone Number: (503) 494 - 2594
- Email: mchill@ohsu.edu
Study Contact Backup
- Name: Brooke M Shafer
- Phone Number: (503) 494 - 0670
- Email: shaferb@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
Contact:
- Andrew McHill, PhD
- Phone Number: (503) 949-2594
- Email: mchill@ohsu.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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:
- 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 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
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).
|
Maintained consistent sleep onset time (±30 min self-selected sleep time) for 12-weeks.
|
|
No Intervention: Control Group
All other participants will be instructed to maintain their habitual sleep patterns.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in dim-light melatonin onset
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in SRI
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in vascular endothelial function
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in heart rate
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in blood pressure
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in resting cardiac vagal tone
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in heart rate response to exercise
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in blood pressure response to exercise
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in energy metabolism
Time Frame: Week 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.
|
Week 0 and Week 12
|
|
Changes in glucose
Time Frame: Week 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.
|
Week 0 and Week 12
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in MDA
Time Frame: Week 0 and Week 12
|
Changes in malondialdehyde [MDA] will be measured 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.
|
Week 0 and Week 12
|
|
Changes in TAC
Time Frame: Week 0 and Week 12
|
Changes in total antioxidant capacity [TAC] will be measured 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.
|
Week 0 and Week 12
|
|
Changes in CRP
Time Frame: Week 0 and Week 12
|
Changes in C-reactive protein [CRP] will be measured 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.
|
Week 0 and Week 12
|
|
Changes in triglycerides
Time Frame: Week 0 and Week 12
|
Changes in triglycerides will be measured 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.
|
Week 0 and Week 12
|
|
Changes in percent body fat
Time Frame: Week 0 and Week 12
|
Percent body fat will be assessed via dual x-ray absorptiometry [DEXA] and a Tanita body composition scale in all participants at baseline.
Changes in percent body fat will be assessed via DEXA (Intervention Group) and Tanita body composition scale (Control Group) post-12-weeks.
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.
|
Week 0 and Week 12
|
|
Changes in weight
Time Frame: Week 0 and Week 12
|
Weight will be assessed via dual x-ray absorptiometry [DEXA] and a Tanita body composition scale in all participants at baseline.
Changes in weight will be assessed via DEXA (Intervention Group) and Tanita body composition scale (Control Group) post-12-weeks.
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.
|
Week 0 and Week 12
|
|
Changes in BMI
Time Frame: Week 0 and Week 12
|
Body mass index [BMI] will be assessed via dual x-ray absorptiometry [DEXA] and a Tanita body composition scale in all participants at baseline.
Changes in BMI will be assessed via DEXA (Intervention Group) and Tanita body composition scale (Control Group) post-12-weeks.
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.
|
Week 0 and Week 12
|
|
Changes in PIPR
Time Frame: Week 0 and Week 12
|
Changes in post illumination pupil response [PIPR] will be measured using a near-infrared illumination and solid-state video 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.
|
Week 0 and Week 12
|
|
Subjective Pain
Time Frame: Week 0 and Week 12
|
Participants will rate feelings of subjective pain on visual analog scales.
|
Week 0 and Week 12
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Andrew W McHill, PhD, Oregon Health and Science University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- STUDY00026854
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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