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NCT Number: NCT06949722

Redirecting Poor Sleep Drivers of Early Cardiovascular Disease

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).

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Key information

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National University of Singapore

Singapore, 119077

Location status: Recruiting

Location contact

Ju Lynn Ong, PhD

CONTACT

[email protected]

About this study

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.

  • 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 ?
  • How are sleep patterns, in terms of duration, timing, efficiency and regularity, associated with vascular aging patterns?
  • How are patterns of subjective wellbeing related to cardiovascular health, at baseline and follow-up ?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sleep time

    Time frame: Across the 2 year study

    The 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.

  2. Sleep duration

    Time frame: Across the 2 year study

    The 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.

  3. Wake after sleep onset

    Time frame: Across the 2 year study

    The 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.

  4. Sleep regularity

    Time frame: Across the 2 year study

    The 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.

  5. Well-being

    Time frame: Across the 2 year study

    Participants 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.

  6. Major adverse cardiovascular event

    Time frame: Across the 2 year study

    Composite of cardiac death, non-fatal myocardial infarction, resuscitated cardiac arrest, non-fatal ischemic stroke, congestive heart failure, coronary revascularization

  7. Arterial stiffness

    Time frame: Across the 2 year study

    Pulse wave velocity and arterial stiffness measurements will be recorded using applanation tonometry

  8. Vascular age

    Time frame: Across the 2 year study

    Vascular age is calculated using arterial stiffness and traditional cardiovascular risk factors to infer about vascular health.

Secondary outcomes

  1. Predicted vascular age

    Time frame: Across the 2 year study

    Vascular age will be predicted using PPG data and machine learning approaches.

Study contacts

Contact information is provided by the study sponsor or research team.

Gizem Yilmaz, PhD

CONTACT

[email protected]

+6566015238

Ju Lynn Ong, PhD

CONTACT

[email protected]

+6566015238

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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