Clinical trial NCT06949722: Redirecting Poor Sleep Drivers of Early Cardiovascular Disease
Official title: Redirecting Poor Sleep Drivers of Early Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep
Cardiovascular Risk Factors
Keywords: Sleep
Cardiovascular disease
Wearables
Cardiovascular risk
Objective sleep tracking
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 1500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep time
timeFrame: Across the 2 year study
measure: Sleep duration
timeFrame: Across the 2 year study
measure: Wake after sleep onset
timeFrame: Across the 2 year study
measure: Sleep regularity
timeFrame: Across the 2 year study
measure: Well-being
timeFrame: Across the 2 year study
measure: Major adverse cardiovascular event
timeFrame: Across the 2 year study
measure: Arterial stiffness
timeFrame: Across the 2 year study
measure: Vascular age
timeFrame: Across the 2 year study
Secondary outcomes:
measure: Predicted vascular age
timeFrame: Across the 2 year study
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University of Singapore
Study officials:
References: