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Redirecting Poor Sleep Drivers of Early Cardiovascular Disease

Redirecting Poor Sleep Drivers of Early Cardiovascular Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06949722
Enrollment
1500
Registered
2025-04-29
Start date
2025-03-24
Completion date
2027-12-31
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Risk Factors, Sleep

Keywords

Sleep, Cardiovascular disease, Wearables, Cardiovascular risk, Objective sleep tracking

Brief summary

Sleep health is a critical component of cardiovascular well-being, and poor sleep has been linked with increased risk for all-cause mortality including cardiovascular disease (CVD). Moreover, many individuals within a population may have underlying, subclinical cardiovascular conditions, such as hypertension and arterial stiffness, and these may risk progressing to advanced CVD when coupled with inadequate sleep duration and quality. Given that Singapore ranks as the third most sleep-deprived city globally, understanding the relationship between sleep health and the prevalence and progression of CVD becomes increasingly important for population health. In addition, depression and psychological stress could also lead to poorer cardiovascular health by increasing blood cholesterol, blood sugar and blood pressure, and could also be directly related to or arise as a result of poor sleep. The aim of the current study is to track sleep and mental health using a combination of objective sleep tracking (Oura ring) and smartphone-based questionnaires (EMA), and examine their associations with detailed cardiovascular health data collected by the project RESET (Redirecting Immune, Lipid and Metabolic Drivers of Early Cardiovascular Disease).

Detailed description

Sleep health is a critical component of cardiovascular well-being, and poor sleep has been linked with increased risk for all-cause mortality including cardiovascular disease (CVD). Previous research suggested that inadequate duration and quality of sleep may increase the risk for developing cardiovascular disease. Moreover, many individuals within a population may have underlying, subclinical cardiovascular conditions, such as hypertension and arterial stiffness, and these may risk progressing to advanced CVD when coupled with poor sleep. Given that Singapore ranks as the third most sleep-deprived city globally, understanding the relationship between sleep health and the prevalence and progression of CVD becomes increasingly important for population health. In addition, depression and psychological stress could also lead to poorer cardiovascular health. by increasing blood cholesterol, blood sugar and blood pressure, and could also be directly related to or arise as a result of poor sleep. Therefore, it is essential to assess the relationship between CVD progression and sleep as a multidimensional construct with overlapping components, including duration, timing, regularity, and efficiency, using objectively collected data over multiple days. Through the combination of objective sleep tracking through wearables with health assessments conducted in the RESET study (registered with ClinicalTrials.gov under NCT06211868), we will gain valuable insights into these dimensions of poor sleep and wellbeing factors that are associated with poor cardiovascular health. The investigators aim to examine following questions using a combination of objective sleep tracking (Oura ring), smartphone-based questionnaires (EMA) and detailed health data collected by the RESET study. 1. How are sleep patterns, in terms of duration, timing, efficiency and regularity, associated with cardiovascular health outcomes and disease risk, at baseline and follow-up ? 2. How are sleep patterns, in terms of duration, timing, efficiency and regularity, associated with vascular aging patterns? 3. How are patterns of subjective wellbeing related to cardiovascular health, at baseline and follow-up ? 4. Do sleep and subjective wellbeing measures relate on a day to day basis? The investigators hypothesize that inadequate sleep duration, timing, and regularity will be associated with increased cardiovascular risk at baseline and follow-up. Individuals with irregular sleep duration and timing are expected to demonstrate higher arterial stiffness and profiles indicative of early vascular aging. Additionally, participants reporting poor subjective well-being are anticipated to experience poorer sleep quality, which will further associate with increased cardiovascular risk.

Interventions

None listed

Sponsors

National University of Singapore
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Willing to wear a ring * Have any of the following conditions: * High blood pressure * High cholesterol * Fatty liver * Family history of heart diseases or stroke. * Obesity

Exclusion criteria

* Prior history of heart attack or stroke or balloon angioplasty/stent placement * Restricted peripheral circulation (e.g., Raynaud's disease) * Pacemakers

Design outcomes

Primary

MeasureTime frameDescription
Vascular ageAcross the 2 year studyVascular age is calculated using arterial stiffness and traditional cardiovascular risk factors to infer about vascular health.
Well-beingAcross the 2 year studyParticipants input ratings about a rotating set of questions concerning wellbeing daily through a smartphone based app (Z4IP) that has been used in prior studies. This daily assessment can be done anytime between 8pm and 12am each day. Higher scores represent higher levels of well-being.
Major adverse cardiovascular eventAcross the 2 year studyComposite of cardiac death, non-fatal myocardial infarction, resuscitated cardiac arrest, non-fatal ischemic stroke, congestive heart failure, coronary revascularization
Sleep timeAcross the 2 year studyThe Oura ring is a device worn on the finger which non-invasively records movement, heart rate and temperature to infer sleep and physical activity. Sleep Onset Time, Wake Time, on Workday (weekday) and Free Day (Weekend / vacation) will be recorded for nocturnal sleep and naps.
Sleep durationAcross the 2 year studyThe Oura ring is a device worn on the finger which non-invasively records movement, heart rate and temperature to infer sleep and physical activity. Sleep Duration on Workday (weekday) and Free Day (Weekend / vacation) will be recorded for nocturnal sleep and naps.
Wake after sleep onsetAcross the 2 year studyThe Oura ring is a device worn on the finger which non-invasively records movement, heart rate and temperature to infer sleep and physical activity. Wake after Sleep Onset on Workday (weekday) and Free Day (Weekend / vacation) will be recorded.
Sleep regularityAcross the 2 year studyThe Oura ring is a device worn on the finger which non-invasively records movement, heart rate and temperature to infer sleep and physical activity. Sleep Regularity (computed via Std Deviation and Sleep Regularity Index; evaluated over 4 weeks minimally) will be recorded.
Arterial stiffnessAcross the 2 year studyPulse wave velocity and arterial stiffness measurements will be recorded using applanation tonometry

Secondary

MeasureTime frameDescription
Predicted vascular ageAcross the 2 year studyVascular age will be predicted using PPG data and machine learning approaches.

Countries

Singapore

Contacts

Primary ContactJu Lynn Ong, PhD
julynn.ong@nus.edu.sg+6566015238
Backup ContactGizem Yilmaz, PhD
gizem.yilmaz@nus.edu.sg+6566015238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026