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Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol
- Source :
- BMJ Open. 13:e072853
- Publication Year :
- 2023
- Publisher :
- BMJ, 2023.
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Abstract
- IntroductionAlthough treatment of obstructive sleep apnoea (OSA) using continuous positive airway pressure (CPAP) reduces blood pressure (BP), adherence to CPAP is often suboptimal. A mandibular advancement device (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 analysisThis 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 2) and apnoea–hypopnoea index (30 vs Ethics and disseminationThe 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 numberNCT04119999.
- Subjects :
- General Medicine
Subjects
Details
- ISSN :
- 20446055
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- BMJ Open
- Accession number :
- edsair.doi...........a4944dae43e483ebd5d4d9626d9a0dff