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) and blood pressure reduction. OSA and hypertension are highly prevalent disorders with profound impacts on health. Apart from improving quality of-life, an effective OSA treatment could improve cardiovascular risk partly through blood pressure reduction, particularly in patients with high cardiovascular risk in whom blood pressure control is often suboptimal. Although CPAP is useful, the high non-acceptance and non-adherence preclude its widespread use. East Asians have a restrictive craniofacial phenotype that predisposes them to OSA and the associated cardiovascular stress. CPAP, while considered the first-line therapy for OSA, has failed to improve cardiovascular outcomes in randomized trials till date because it is poorly tolerated. MADs are oral appliances that correct the restrictive craniofacial phenotype present in East Asians by protruding the lower jaw to reduce upper airway collapsibility. MADs are better tolerated than CPAP, and this may be an important determinant of the overall effectiveness in treating OSA, and thus ameliorating the downstream adverse health outcomes. We hypothesize that MADs are non-inferior to CPAP in treating OSA and reducing cardiovascular risk by blood pressure reduction in East Asians. We will recruit East Asian subjects with hypertension and high cardiovascular risk for polysomnography. Patients diagnosed with OSA (n=220) will be randomized to MAD or CPAP groups in a 1:1 ratio for a treatment duration of 6 months. The primary endpoint is the 24-hour mean blood pressure as determined by ambulatory monitoring. The secondary endpoints include sleep-time systolic BP, target blood pressure, cardiovascular biomarkers, and myocardial remodeling. Association between OSA and silent paroxysmal atrial fibrillation will also be determined. If MADs are shown to be effective, the next step is to evaluate our novel device- drug-eluting MAD that the team is developing.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
321
Mandibular advancement device (MAD) has been a novel method in the management of snoring and OSA. For mild to moderate sleep apnea, MADs have been a boon. A guideline published by American Academy of Sleep Medicine stated that MAD was indicated as first-line therapy for mild OSA and a second-line therapy for moderate to severe OSA
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people with OSA
NUHS Cardiosleep research laboratory
Singapore, Singapore
24-hour mean BP (24MBP)
Difference in 24-hour mean BP (24MBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Time frame: 6 months
24-hour systolic BP (24SBP)
Difference in 24-hour systolic BP (24SBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Time frame: 6 months and 12 months
24-hour pulse pressure (24PP)
Difference in 24-hour pulse pressure (24PP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Time frame: 6 months and 12 months
Nocturnal dipping
Difference in prevalence of nocturnal dipping between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.
Time frame: 6 months and 12 months
Ectopic beat
Difference in prevalence of ectopic beats between the patients in the MAD and CPAP groups as determined by continuous ECG monitoring
Time frame: 12 months
Myocardial remodeling
Difference in LV and LA dimensions between the patients in the MAD and CPAP groups as determined by cardiac MRI
Time frame: 12 months
Epworth Sleepiness Scale (ESS) score
Difference in change in ESS score between the MAD and CPAP groups
Time frame: 6 months and 12 months
Sleep Apnea Quality of Life Index (SAQLI)
Difference in change in SAQLI score between the MAD and CPAP groups
Time frame: 6 months and 12 months
Functional Outcome of Sleep Questionnaire (FOSQ)
Difference in change in SAQLI score between the MAD and CPAP groups
Time frame: 6 months and 12 months
36-Item Short Form Health Survey (SF-36)
Difference in change in SF-36 score between the MAD and CPAP groups
Time frame: 6 months and 12 months
EuroQol 5Q (EQ5D)
Difference in change in EQ5D score between the MAD and CPAP groups
Time frame: 6 months and 12 months
Daytime systolic BP
Difference in change in daytime systolic BP between the patients in the MAD and CPAP
Time frame: 6 months and 12 months
Nighttime systolic BP
Difference in change in nighttime systolic BP between the patients in the MAD and CPAP
Time frame: 6 months and 12 months
Percentage of patient with 24-hour systolic BP<130 mmHg
Difference in percentage of patients with 24-hour systolic BP\<130 mmHg in the MAD and CPAP groups
Time frame: 6 months and 12 months
Percentage of patient with 24-hour systolic BP<120 mmHg
Difference in percentage of patients with 24-hour systolic BP\<120 mmHg in the MAD and CPAP groups
Time frame: 6 months and 12 months
NT-proBNP
Change in the plasma level of NT-proBNP from baseline to 6-month follow-up
Time frame: 6 months and 12 months
High sensitivity troponin
Change in the plasma level of high sensitivity troponin from baseline to 6-month follow-up
Time frame: 6 months and 12 months
High sensitive C-reactive protein
Change in the plasma level of high sensitive C-reactive protein from baseline to 6-month follow-up
Time frame: 6 months and 12 months
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