The Influence of Sleep on Cardiovascular Outcomes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorOregon Health and Science University
About this trial
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
This trial accepts healthy volunteersQualifiers
Ostensibly healthy men and women Subgroup study (chronic pain)
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Sleep Regularity Group
BehavioralMaintained consistent sleep onset time (±30 min self-selected sleep time) for 12-weeks.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Sleep Regularity GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Changes in dim-light melatonin onset
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.
Time frame
Week 0 and Week 122
Changes in SRI
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.
Time frame
Week 0 and Week 123
Changes in vascular endothelial function
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.
Time frame
Week 0 and Week 124
Changes in heart rate
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.
Time frame
Week 0 and Week 12Secondary outcomes
1
Changes in MDA
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.
Time frame
Week 0 and Week 122
Changes in TAC
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.
Time frame
Week 0 and Week 123
Changes in CRP
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.
Time frame
Week 0 and Week 124
Changes in triglycerides
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.
Time frame
Week 0 and Week 12Sponsors and contacts
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Oregon Health and Science University
Lead sponsor
Medical Research Foundation, Oregon
Collaborator
Source ClinicalTrials.gov