Checking sleep apnea and heart outcomes in people with atrial fibrillation
Tests a home sleep study in people with atrial fibrillation and high heart risk.
Key facts
- Who runs it
- National University of Singapore
- Where
- Singapore, SingaporeSee the site
- Trial code
- Registry title
- OSA and CV Outcomes in Patients With High Risk AF
- Status
- Recruiting
- People taking part
- 1,365 people, planned
- Started
- 1 Jul 2019
- Expected to end
- 30 Jun 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Overnight sleep study
- Record updated
- 12 June 2024
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation (AF) who are at high risk of heart and blood vessel disease. They will have a home sleep study to check for sleep apnoea.
- Age
- 22 to 99 years
- Sex
- All sexes can join.
- Disease stage
- Known atrial fibrillation (paroxysmal, persistent or permanent) plus high cardiovascular risk, such as high blood pressure, diabetes, stroke, significant coronary artery disease, chronic kidney disease, or age 75 or older.
- Earlier treatment
- People already on regular CPAP treatment for sleep apnoea cannot join.
Main reasons for not taking part
- Known sleep apnoea treated regularly with CPAP
- Valvular AF (moderate or severe mitral stenosis or a mechanical heart valve)
- A permanent pacemaker
- Life expectancy under 1 year because of other medical conditions
- Pregnant or breastfeeding women
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- Age 22 or above
- Known AF, including paroxysmal, persistent or permanent AF
- High cardiovascular risk, defined as one or more of the following:; hypertension; diabetes mellitus; stroke; significant coronary artery disease (at least one stenosis of >50% diameter in at least one major epicardial artery based on CT or conventional coronary angiography, positive stress test [treadmill, myocardial perfusion scan, or stress echocardiography], previous percutaneous coronary intervention, or previous coronary artery bypass surgery); chronic kidney disease (excluding polycystic kidney disease) with an estimated glomerular filtration rate of <60 ml/min/1.73m2,; 10-year risk of cardiovascular disease of 15% or greater on the basis of the Framingham risk score, or; age of 75 years or older
Who cannot take part
- Life expectancy less than 1 year based on concomitant medical conditions
- Valvular AF (moderate/severe mitral stenosis or mechanical heart valve)
- Known OSA on regular CPAP treatment
- Permanent pacemaker implantation
- Unable to give research consent
- Pregnant or lactating women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 22 and 99 years old?
Where in Singapore
- Chi-Hang LeeSingapore, SingaporeContact: Lee CH Ronald, MDTaking people
About the trial
What the trial wants to find out
The POACH study is part of the Cardiosleep research program. It is a prospective, observational, multicentre study conducted in Singapore. The recruitment target is 1365 patients.
Read full original descriptionShow less
Eligible patients with AF and high cardiovascular risk will be recruited for a home-based sleep study using a FDA-approved portable device. The patients will be divided into 2 groups based on the presence or absence of OSA using apnoea-hypopnoea index ≥ 15 events/hour. The AF will be treated as per local standard practice. Participation in the POACH study will not affect the management of AF. Follow-up will be conducted every 6 months until the median follow-up duration has reached 2 years. The primary endpoint is a four-component composite of all-cause mortality, myocardial infarction, stroke and heart failure hospitalisation.
Antecubital venous blood samples will be taken from the patients in the morning after the sleep study for targeted mass spectrometry which will measure 83 circulating metabolites. Sparse Principal Component Analysis will be used for data reduction. Identification of distinct associations between metabolic perturbations and OSA will be performed.
The 2 groups in the trial
- OSA (Watch PAT AHI >/= 15 events per hour)
Patients found to have OSA by an overnight sleep study
Treatment: Overnight sleep study
- Non-OSA (Watch PAT AHI < 15 events per hour)
Patients found NOT to have OSA by an overnight sleep study
Treatment: Overnight sleep study
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prospective Study on Obstructive Sleep Apnea and Cardiovascular Outcomes in Patients With Atrial Fibrillation and High Cardiovascular Risk
- Plain-language title
- Checking sleep apnea and heart outcomes in people with atrial fibrillationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04005508, who can take part
- Record updated
- 12 June 2024