SleepNCT06949722
Redirecting Poor Sleep Drivers of Early Cardiovascular Disease
An observational study of Sleep and Cardiovascular Risk Factors, run by National University of Singapore at 1 site in Singapore.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Sleep, Cardiovascular Risk Factors
- How many people
- 1,500 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Mar 2025to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).
Who may be able to join
- 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
Who cannot join
- Prior history of heart attack or stroke or balloon angioplasty/stent placement
- Restricted peripheral circulation (e.g., Raynaud's disease)
- Pacemakers
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University of Singapore
Singapore, 119077
Ju Lynn Ong, PhD, julynn.ong@nus.edu.sg
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). 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).
Read the 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.
- 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.
- Conditions
- Sleep, Cardiovascular Risk Factors
- Keywords
- Sleep, Cardiovascular disease, Wearables, Cardiovascular risk, Objective sleep tracking
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Across the 2 year study
Arterial stiffness
Pulse wave velocity and arterial stiffness measurements will be recorded using applanation tonometry
Measured: Across the 2 year study
Vascular age
Vascular age is calculated using arterial stiffness and traditional cardiovascular risk factors to infer about vascular health.
Measured: Across the 2 year study
Secondary outcomes (1)
Predicted vascular age
Vascular age will be predicted using PPG data and machine learning approaches.
Measured: Across the 2 year study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start24 Mar 2025
- Primary completion15 Aug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael W.L. Chee, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949722
- Sponsor's protocol ID
- RESET-Sleep
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redirecting Poor Sleep Drivers of Early Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT06949722
- Acronym / sponsor ID
- RESET-Sleep
- Conditions
- Sleep, Cardiovascular Risk Factors
- Keywords
- Sleep, Cardiovascular disease, Wearables, Cardiovascular risk, Objective sleep tracking
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 15 Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- South-East Asian population aged 40-70 years with no prior manifest atherosclerotic cardiovascular disease (ACSVD).
Key inclusion criteria (7 listed)
- Willing to wear a ring
- Have any of the following conditions:
Key exclusion criteria (3 listed)
- Prior history of heart attack or stroke or balloon angioplasty/stent placement
- Restricted peripheral circulation (e.g., Raynaud's disease)
- Pacemakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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
Arterial stiffness
Time frame: Across the 2 year study
Pulse wave velocity and arterial stiffness measurements will be recorded using applanation tonometry
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.
1 secondary outcome
Predicted vascular age
Time frame: Across the 2 year study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Cardiovascular Risk Factors, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ju Lynn Ong, PhD (+6566015238, julynn.ong@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep time (time frame: Across the 2 year study). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.