Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol
Introduction Although 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 ev...
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| Format: | Article |
| Language: | English |
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BMJ Publishing Group
2023-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/5/e072853.full |
| _version_ | 1797814314856349696 |
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| author | Pipin Kojodjojo Peter Cistulli Philip Wong Chi-Hang Lee Siew-Pang Chan William Kong Yi-Hui Ou Juliana Tereza Colpani Weiqiang Loke Crystal S Cheong Calvin W Chin |
| author_facet | Pipin Kojodjojo Peter Cistulli Philip Wong Chi-Hang Lee Siew-Pang Chan William Kong Yi-Hui Ou Juliana Tereza Colpani Weiqiang Loke Crystal S Cheong Calvin W Chin |
| author_sort | Pipin Kojodjojo |
| collection | DOAJ |
| description | Introduction Although 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 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/m2) 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.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. |
| first_indexed | 2024-03-13T08:05:50Z |
| format | Article |
| id | doaj.art-fcf7d7b5a9c1482b8b6b4384dc2101f7 |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-13T08:05:50Z |
| publishDate | 2023-05-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-fcf7d7b5a9c1482b8b6b4384dc2101f72023-06-01T06:30:05ZengBMJ Publishing GroupBMJ Open2044-60552023-05-0113510.1136/bmjopen-2023-072853Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocolPipin Kojodjojo0Peter Cistulli1Philip Wong2Chi-Hang Lee3Siew-Pang Chan4William Kong5Yi-Hui Ou6Juliana Tereza Colpani7Weiqiang Loke8Crystal S Cheong9Calvin W Chin10Cardiology, National University Heart Centre, Singapore13 Sleep Research Group, Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, AustraliaMercyAscot, Auckland, New ZealandNational University Heart Centre, SingaporeCardiology, National University Heart Centre, Singapore4 Department of Cardiology, National University Heart Centre Singapore, National University Health System, SingaporeDepartment of Medicine, National University of Singapore, SingaporeDepartment of Endodontics, Operative Dentistry and Prosthodontics, National University of Singapore, SingaporeDepartment of Endodontics, Operative Dentistry and Prosthodontics, National University of Singapore, SingaporeDepartment of Otolaryngology-Head and Neck Surgery, National University Hospital, SingaporeDepartment of Cardiology, National Heart Centre Singapore, SingaporeIntroduction Although 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 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/m2) 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.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.https://bmjopen.bmj.com/content/13/5/e072853.full |
| spellingShingle | Pipin Kojodjojo Peter Cistulli Philip Wong Chi-Hang Lee Siew-Pang Chan William Kong Yi-Hui Ou Juliana Tereza Colpani Weiqiang Loke Crystal S Cheong Calvin W Chin Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol BMJ Open |
| title | Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol |
| title_full | Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol |
| title_fullStr | Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol |
| title_full_unstemmed | Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol |
| title_short | Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol |
| title_sort | mandibular advancement device versus cpap in lowering 24 hour blood pressure in patients with obstructive sleep apnoea and hypertension the crescent trial protocol |
| url | https://bmjopen.bmj.com/content/13/5/e072853.full |
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