Status:
COMPLETED
A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling
Lead Sponsor:
National University of Singapore
Collaborating Sponsors:
Ng Teng Fong General Hospital
National University Hospital, Singapore
Conditions:
Hypertension,Essential
Obstructive Sleep Apnea
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The objective of this proposal is to evaluate whether mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA...
Eligibility Criteria
Inclusion
- Age of at least 40 years
- Chinese (based on the Identity Card or other Identity Document if the subject is a non-Singapore citizen or permanent resident)
- Physician diagnosed essential hypertension, on at least 1 medication for BP control
- High cardiovascular risk, as defined by one or more of the following: (a) diabetes mellitus, (b) stroke, (c) significant coronary artery disease (at least one stenosis of \>50% diameter in at least one major epicardial artery), (d) chronic kidney disease, excluding polycystic kidney disease, with an estimated glomerular filtration rate of \<60 ml/min/1.73m2, or (e) age of 75 years or older.
Exclusion
- Known OSA on treatment
- Cheyne-Stokes breathing or predominantly central sleep apnea (\>50%)
- Known secondary hypertension: from renal (renal artery stenosis, chronic renal failure); endocrine (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism) or cardiac causes (aortic coarctation)
- Contraindications to CMR: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF \<30ml/min/1.73m2), claustrophobia and pregnant women
- Contraindications to MAD: \<6 to 10 teeth in each arch, inability to advance the mandible and open the jaw widely, pre-existing temporomandibular joint problems, severe bruxism
- Limited life expectancy (\< 1 year)
- Hypertensive crisis, acute coronary syndromes or acute heart failure in the past 30 days
- Known AF (not suitable for CMR and affects remodelling analysis)
Key Trial Info
Start Date :
October 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2024
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT04119999
Start Date
October 16 2019
End Date
February 15 2024
Last Update
February 20 2024
Active Locations (1)
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1
NUHS Cardiosleep research laboratory
Singapore, Singapore