Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol

May 31, 2023BMJ open

Comparing Mouthpiece and CPAP Treatments for Lowering 24-Hour Blood Pressure in Sleep Apnea and High Blood Pressure Patients

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Abstract

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.

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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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Mandibular advancement device versus CPAP in lowering 24-hour blood pressure in patients with obstructive sleep apnoea and hypertension: the CRESCENT trial protocol

Abstract

Key numbers

Full Text

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