干预措施以提高阻塞性睡眠呼吸暂停患者对下颌前伸装置的依从性：一项随机临床试验的研究方案。
Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial.
机构信息
Centre of Oral Bioengineering, Institute of Dentistry, Queen Mary University of London, Turner Street, London, E1 2AD, UK.
Department of Population and Patient Health, Faculty of Dentistry, Oral & Craniofacial Sciences, King's College London, London, UK.
出版信息
Trials. 2021 Oct 13;22(1):699. doi: 10.1186/s13063-021-05582-1.
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.
背景
阻塞性睡眠呼吸暂停（OSA）是一种与睡眠相关的呼吸障碍，其特征是睡眠期间上呼吸道反复间歇性塌陷，导致睡眠剥夺，出现呼吸暂停和低通气。根据 OSA 的严重程度，有两种主要的治疗方法，持续气道正压通气（CPAP）和下颌前伸装置（MAA）；两者均依赖于依从性。MAA 适用于轻度至中度 OSA 患者，并作为不耐受 CPAP 患者的替代治疗方法。然而，MAA 治疗的依从性是可变的，并随时间推移而下降。因此，本研究旨在评估阶段匹配干预措施，健康行动过程方法（HAPA），对 OSA 患者 MAA 依从性的有效性。
方法
将在 Bart's Health NHS Trust 进行单中心随机临床试验。计划招募 56 名新诊断为 OSA 的患者参与研究，并随机分为干预组（IC）和标准护理组（SC）。SC 组患者将接受常规护理，而 IC 组患者将接受使用 HAPA 模型开发的阶段匹配干预。将从 MAA 设计中嵌入的微传感器和睡眠日记中分别以 3、6、18 和 36 个月的时间点收集客观和主观的 MAA 依从性数据。此外，还将使用一系列旨在评估风险感知、结果预期和自我效能（SEMSA）以及睡眠质量（PSQI 和 ESS）和生活质量（EQ-5DL）、社会经济和社会支持量表的问卷。
讨论
目前治疗阻塞性睡眠呼吸暂停的方法完全取决于患者的接受和使用。有几个因素会影响合作和佩戴，例如患者对自己病情的认识、社会支持和心理行为。此外，情绪，如焦虑、压力和抑郁，也可能会影响佩戴。同时，我们知道，涉及更多教育和行为方法的干预措施可以帮助患者更容易适应某些治疗方法。因此，本试验旨在探讨这些因素的潜在作用，以最大限度地提高治疗效果并减少副作用。
试验注册
ClinicalTrials.gov NCT04092660。于 2019 年 9 月 6 日注册。
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