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

Harishri Tallamraju,J Tim Newton,Padhraig S Fleming,Ama Johal

doi:10.1186/s13063-021-05582-1

Abstract

BackgroundObstructive 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.MethodsA 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.DiscussionThe 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 registrationClinicalTrials.gov NCT04092660. Registered on September 6, 2019

Highlights

Background and rationale {6a} 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 [1]
An overnight sleep study is required to establish a diagnosis of OSA and provides the apnoea-hypopnoea index (AHI), which is the sum of the average number of apnoea and hypopnoea events per hour of sleep
Studies have consistently demonstrated that continuous positive airway pressure (CPAP) is more effective than mandibular advancement appliances (MAA) at reducing sleep-disordered breathing and achieving complete control of OSA (AHI < 5) [10]

Summary

Methods

Study setting {9} The study will be undertaken at the Royal London Dental Hospital, Bart’s Health NHS Trust in line with the CONSORT guidelines. Additional consent provisions for collection and use of participant data and biological specimens {26b} Not applicable objectively and subjectively at 3, 6, 18 and 36 months to assess the effectiveness of the interventions in enhancing adherence to MAA. The strategies employed to improve adherence to the intervention i.e. the MAA therapy have been designed on the principles on the behaviour change model, HAPA Patients requiring mandibular advancement appliance (MAA) therapy are referred to specific dental sleep clinics for treatment, as part of a multi-disciplinary approach to care. We suggest participants to seek feedback from their family, especially their sleeping partner regarding their improvement This type of support motivates the patient to work more towards achieving their goals. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} Not applicable

Discussion

Introduction

Statistical methods

Findings

Availability of data and materials Not applicable