A total of 220 participants with moderate-to-severe will be randomized to receive either a or therapy.
The primary outcome measures the difference in 24-hour mean arterial blood pressure between baseline and 6 months.
Secondary outcomes include various measures of blood pressure, heart rhythm analysis, and quality-of-life assessments.
An adaptive randomization scheme will ensure balanced distribution based on age, body mass index, and apnoea-hypopnoea index.
The study aims to determine if the mandibular advancement device is non-inferior to continuous positive airway pressure in reducing blood pressure.
Recruitment for the trial commenced in October 2019 and concluded in December 2022.
Simplified
INTRODUCTION: Although treatment of (OSA) using (CPAP) reduces blood pressure (BP), adherence to CPAP is often suboptimal. A (MAD) is a guideline-endorsed alternative therapy for OSA. Still, there is limited evidence on the relative efficacy between MAD and CPAP on BP reduction. We evaluate whether treatment of moderate-to-severe OSA using MAD can improve BP and other health-related outcomes compared with CPAP.
METHODS AND ANALYSIS: This is a randomised, controlled, non-inferiority trial conducted. We will recruit 220 Asians with a history of hypertension and high cardiovascular risk for an overnight polysomnography screening. Those with moderate-to-severe OSA (apnoea-hypopnoea index ≥15 events/hour) will be randomised to treatment with either MAD or CPAP in a 1:1 ratio. Stratified by age (60 vs <60 years old), body mass index (25 vs <25 kg/m) and apnoea-hypopnoea index (30 vs <30 events/hour), an adaptive randomisation scheme with permuted blocks constructed in real-time is implemented to restrict imbalance. The overall study duration is 12 months. The primary endpoint is the 24-hour mean arterial BP difference between baseline and 6-month follow-up. The secondary endpoints include other measures of ambulatory BP monitoring, arrhythmia based on a 4-day electrocardiographic monitoring, biomarker and proteomic analysis, cardiovascular magnetic resonance-derived myocardial fibrosis and remodelling and quality-of-life questionnaires. Recruitment began in October 2019 and ended in December 2022. Comparison between MAD and CPAP will be performed using covariance (ANCOVA) analysis of the changes in 24-hour mean arterial BP while adjusting for the baseline 24-hour mean arterial BP. We will compare the 95% CIs around the treatment difference point estimate with the prespecified non-inferiority margin (1.5 mm Hg). If the upper limit of the 95% CI is <1.5 mm Hg and crosses 0, non-inferiority of the MAD relative to CPAP will be established. 2
ETHICS AND DISSEMINATION: The Domain Specific Review Board-C, National Healthcare Group under approved the study protocol (NHG DSRB Ref: 2019/00359, approved on 28 August 2019). Study findings will be disseminated to various local, national, and international audiences through abstract presentations and publication in peer-reviewed journals.
TRIAL REGISTRATION NUMBER: NCT04119999.
Key numbers
220
Sample Size
Total participants recruited for the trial.
1.5 mm Hg
Non-inferiority Margin
Prespecified non-inferiority margin for blood pressure difference.
38 months
Recruitment Duration
Total recruitment period for the trial.
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Competing interests: PW is a founder of WEB bio which develops the Spyder device. PC has an appointment as an endowed Academic Chair at the University of Sydney that was created from ResMed funding; he receives no personal fees, and this relationship is managed by an Oversight Committee of the University. Additionally, he has received research support from ResMed, SomnoMed, Zephyr Sleep Technologies, and Bayer, and is a consultant/adviser to Signifier Medical Technologies, SomnoMed, ResMed, Bayer and Sunrise Medical.
PubMed
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