Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06535178
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
The Influence of Sleep on Cardiovascular Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Determining the Influence of Sleep on Cardiovascular Outcomes
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DISCO
Brief 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
Detailed Description:
Sleep is a fundamental determinant of heath however the impact of day-to-day variations in sleep patterns ie 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 eg sleep with the internal timing system ie 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
1 Outpatient Biobehavioral Weeks Actigraphy data will be collected across 2-weeks to assess habitual sleep patterns and calculate a sleep regularity index SRI
2 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 75h 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
3 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
4 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
The misalignment of behaviors eg sleep with the internal timing system ie 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
1 Outpatient Biobehavioral Weeks Actigraphy data will be collected across 2-weeks to assess habitual sleep patterns and calculate a sleep regularity index SRI
2 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 75h 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
3 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
4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None