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Recruiting NCT06949722

Redirecting Poor Sleep Drivers of Early Cardiovascular Disease

Observational Sleep Cardiovascular Risk Factors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sleep, Cardiovascular Risk Factors. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Sleep time [Time frame: Across the 2 year study]
  • Sleep duration [Time frame: Across the 2 year study]
  • Wake after sleep onset [Time frame: Across the 2 year study]
  • Sleep regularity [Time frame: Across the 2 year study]
  • Well-being [Time frame: Across the 2 year study]
  • Major adverse cardiovascular event [Time frame: Across the 2 year study]
  • Arterial stiffness [Time frame: Across the 2 year study]
  • Vascular age [Time frame: Across the 2 year study]
Secondary outcome measures (1)
  • Predicted vascular age [Time frame: Across the 2 year study]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Singapore · 1 center
  • National University of Singapore — Singapore

Identifiers

NCT: NCT06949722 · RESET-Sleep

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗