Msaad Sameh, Abdelmouleh Dorra, Khemakhem Rim, Gargouri Rahma, Kallel Nesrine, Maalej Manel, Turki Manel, Chaari Imen, Abid Narjes, Younes Asma, Bahloul Najla, Kammmoun Samy
Faculty of Medicine of Sfax, University of Sfax-Sfax, Tunisia.
Department of Respiratory and Sleep Medicine, University Hospital Hedi Chaker, Sfax, Tunisia.
PLoS One. 2025 May 30;20(5):e0322285. doi: 10.1371/journal.pone.0322285. eCollection 2025.
Poor patient adherence to continuous positive airway pressure (CPAP) remains a common challenging issue and a major cause of treatment failure in patients with obstructive sleep apnea-hypopnea syndrome (OSAHS). Our study aims to test the hypothesis that therapeutic patient education (TPE) combined with augmented clinical support (ACS) at CPAP initiation would improve CPAP adherence and treatment outcomes compared to usual care.
We will perform a prospective, randomized, controlled, parallel-group trial including 60 adult patients newly diagnosed with severe OSAHS. Each patient will be randomly assigned to either the TPE group or the usual care group and then scheduled to start CPAP therapy within 1-2 weeks after the nocturnal polygraph recording. For the TPE group, CPAP initiation will be performed at the hospital during a 3-hour educational session that will include 4 workshops entitled: "What's OSAHS", "CPAP machine: what is it? How does it work? And what does it serve for?", "How to use your CPAP and fit your mask" and "How to deal with CPAP side effects". The educational team will include a sleep disorders specialist, a sleep nurse, and a CPAP technician. As educational tools, we will use a short storytelling video in the local language, live demonstrations and a daily desk calendar with 60 removable sheets and 1 tip on CPAP therapy on each sheet. Patients assigned to the usual care group will undergo CPAP initiation at home under the guidance of a CPAP technician and will not receive additional educational support beyond the documents provided by the manufacturers. Our primary outcome is unadjusted CPAP adherence measured in hours/night at 1, 3, and 6 months after CPAP initiation. Our secondary outcome is functional status at the 6-month follow-up, which included snoring, nasal obstruction symptoms, subjective quality of life, fatigue, emotional status, cognitive function, insomnia and excessive daytime sleepiness (EDS).
We designed this original protocol by combining TPE with ACS. We hope that our findings will help us improve CPAP adherence among Tunisian patients with OSAHS.
患者对持续气道正压通气（CPAP）治疗的依从性差仍然是一个常见的具有挑战性的问题，也是阻塞性睡眠呼吸暂停低通气综合征（OSAHS）患者治疗失败的主要原因。我们的研究旨在验证这一假设：与常规治疗相比，在开始使用CPAP时进行治疗性患者教育（TPE）并加强临床支持（ACS）能够提高CPAP的依从性和治疗效果。
我们将进行一项前瞻性、随机、对照、平行组试验，纳入60例新诊断为重度OSAHS的成年患者。每位患者将被随机分配至TPE组或常规治疗组，然后在夜间多导睡眠图记录后的1 - 2周内开始CPAP治疗。对于TPE组，将在医院进行为期3小时的教育课程以启动CPAP治疗，该课程包括4个工作坊，分别为：“什么是OSAHS”、“CPAP机器：它是什么？如何工作？有什么作用？”、“如何使用CPAP及佩戴面罩”以及“如何应对CPAP的副作用”。教育团队将包括一名睡眠障碍专家、一名睡眠护士和一名CPAP技术人员。作为教育工具，我们将使用当地语言的简短故事视频、现场演示以及一本每日桌面日历，日历有60张可移除的页面，每张页面上有一条关于CPAP治疗的提示。分配至常规治疗组的患者将在CPAP技术人员的指导下在家中开始CPAP治疗，并且除了制造商提供的文件外不会接受额外的教育支持。我们的主要结局是在开始使用CPAP后的1、3和6个月时以每夜使用小时数衡量的未调整CPAP依从性。我们的次要结局是6个月随访时的功能状态，包括打鼾、鼻塞症状、主观生活质量、疲劳、情绪状态、认知功能、失眠和日间过度嗜睡（EDS）。
我们通过将TPE与ACS相结合设计了这个原创方案。我们希望我们的研究结果将有助于提高突尼斯OSAHS患者对CPAP的依从性。
