Redirecting Poor Sleep Drivers of Early Cardiovascular Disease

NCT06949722 | Recruiting

• 1 other identifier: RESET-Sleep
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep; Cardiovascular Risk Factors

Keywords

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

Outcome Measures

Primary Outcomes (8)

• Sleep time

  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.

  Across the 2 year study

• Sleep duration

  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.

  Across the 2 year study

• Wake after sleep onset

  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.

  Across the 2 year study

• Sleep regularity

  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.

  Across the 2 year study

• Well-being

  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.

  Across the 2 year study

• Major adverse cardiovascular event

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

  Across the 2 year study

• Arterial stiffness

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

  Across the 2 year study

• Vascular age

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

  Across the 2 year study

Secondary Outcomes (1)

• Predicted vascular age

  Across the 2 year study

Study Arms (1)

Participants from RESET

Interested participants will be drawn from the RESET cohort which includes South-East Asians aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease.

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, 119077, Singapore

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Ju Lynn Ong, PhD

CONTACT

+6566015238; julynn.ong@nus.edu.sg

Gizem Yilmaz, PhD

CONTACT

+6566015238; gizem.yilmaz@nus.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)