Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial

BACKGROUND: Obstructive sleep apnoea (OSA) is a sleep-related breathing disorder characterised by the repeated episodic collapse of the upper airway during sleep, resulting in sleep deprivation, giving rise to apnoeas and hypopnoeas. Based on the severity of OSA, there are two primary treatment modalities, continuous positive airway pressure (CPAP) and mandibular advancement appliances (MAA); both are adherence-dependent. MAA is offered to those with mild to moderate OSA and is prescribed as an alternative to patients intolerable to CPAP. However, adherence to MAA treatment is variable and declines over time. Hence, the current study aims to assess the effectiveness of the stage-matched intervention, the Health Action Process Approach (HAPA), on adherence to MAA in patients with OSA. METHODS: A single-centre randomised clinical trial will be undertaken at Bart’s Health NHS Trust. Fifty-six participants with newly diagnosed OSA are planned to be enrolled in the study and randomised to intervention care (IC) and standardised care (SC) groups. Participants in the SC group will receive routine care whilst participants in the IC group will receive the stage-matched intervention, developed using the HAPA model. Data indicating MAA adherence will be collected both objectively and subjectively, from micro-sensors embedded in the MAA design and sleep diaries, respectively at 3, 6, 18 and 36 months. In addition, a range of questionnaires designed to assess risk perception, outcome expectancy, and self-efficacy (SEMSA) and quality of sleep (PSQI and ESS) and life (EQ-5DL), socio-economic and social support scales will be used. DISCUSSION: The currently available treatments for obstructive sleep apnoea depend entirely on the patient’s acceptance and use. There are several factors that affect cooperation and wear for example patients’ awareness of their condition, social support and psychological behaviour. In addition, mood, such as anxiety, stress, and depression, may affect wear. At the same time, we know that interventions involving more education and behaviour approaches can help patients adapt more easily to some treatments. As a result, the present trial aims to explore the potential role of these factors to maximise treatment success and minimise side effects. TRIAL REGISTRATION: ClinicalTrials.gov NCT04092660. Registered on September 6, 2019 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05582-1.