Hnatiak Jakub, Zikmund Galkova Lujza, Winnige Petr, Batalik Ladislav, Dosbaba Filip, Ludka Ondrej, Krejci Jan
Department of Rehabilitation, University Hospital Brno, Brno, Czech Republic.
First Department of Internal Medicine - Cardioangiology, St Anne´s University Hospital, Faculty of Medicine, Masaryk University, Brno, Czech Republic.
JMIR Res Protoc. 2023 Sep 18;12:e47460. doi: 10.2196/47460.
Obstructive sleep apnea (OSA) is characterized by recurrent, intermittent partial or complete obstruction of the upper respiratory tract during sleep, which negatively affects the patient's daily quality of life (QoL). Middle-aged and older men who smoke and have obesity are most at risk. Even though the use of continuous positive airway pressure (CPAP) during sleep remains the gold standard treatment, various rehabilitation methods, such as exercise, respiratory therapy, myofunctional therapy, and nutritional lifestyle interventions, also appear to be effective. Moreover, it is increasingly recommended to use alternative or additional therapy options in combination with CPAP therapy.
This study aims to evaluate if a comprehensive home-based, remotely supervised rehabilitation program (tele-RHB), in combination with standard therapy, can improve OSA severity by decreasing the apnea-hypopnea index (AHI); improve objective parameters of polysomnographic, spirometric, anthropometric, and body composition examinations; improve lipid profile, maximal mouth pressure, and functional capacity tests; and enhance the subjective perception of QoL, as well as daytime sleepiness in male participants with moderate to severe OSA. Our hypothesis is that a combination of the tele-RHB program and CPAP therapy will be more effective by improving OSA severity and the abovementioned parameters.
This randomized controlled trial aims to recruit 50 male participants between the ages of 30 and 60 years with newly diagnosed moderate to severe OSA. Participants will be randomized 1:1, either to a 12-week tele-RHB program along with CPAP therapy or to CPAP therapy alone. After the completion of the intervention, the participants will be invited to complete a 1-year follow-up. The primary outcomes will be the polysomnographic value of AHI, Epworth Sleepiness Scale score, 36-Item Short Form Health Survey (SF-36) score, percentage of body fat, 6-minute walk test distance covered, as well as maximal inspiratory and expiratory mouth pressure values. Secondary outcomes will include polysomnographic values of oxygen desaturation index, supine AHI, total sleep time, average heart rate, mean oxygen saturation, and the percentage of time with oxygen saturation below 90%; anthropometric measurements of neck, waist, and hip circumference; BMI values; forced vital capacity; forced expiratory volume in 1 second; World Health Organization's tool to measure QoL (WHOQOL-BREF) score; and lipid profile values.
Study recruitment began on October 25, 2021, and the estimated study completion date is December 2024. Analyses will be performed to examine whether the combination of the tele-RHB program and CPAP therapy will be more effective in the reduction of OSA severity and improvement of QoL, body composition and circumferences, exercise tolerance, lipid profile, as well as respiratory muscle and lung function, compared to CPAP therapy alone.
The study will evaluate the effect of a comprehensive tele-RHB program on selected parameters mentioned above in male participants. The results of this intervention could help the further development of novel additional therapeutic home-based options for OSA.
ClinicalTrials.gov NCT04759456; https://clinicaltrials.gov/ct2/show/NCT04759456.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47460.
阻塞性睡眠呼吸暂停（OSA）的特征是睡眠期间上呼吸道反复、间歇性部分或完全阻塞，这对患者的日常生活质量（QoL）产生负面影响。吸烟且肥胖的中老年男性风险最高。尽管睡眠期间使用持续气道正压通气（CPAP）仍然是金标准治疗方法，但各种康复方法，如运动、呼吸治疗、肌功能治疗和营养生活方式干预，似乎也有效。此外，越来越建议将替代或额外的治疗选择与CPAP治疗联合使用。
本研究旨在评估一项全面的居家远程监督康复计划（tele-RHB）与标准治疗相结合，是否能通过降低呼吸暂停低通气指数（AHI）来改善OSA严重程度；改善多导睡眠图、肺量计、人体测量和身体成分检查的客观参数；改善血脂谱、最大口腔压力和功能能力测试；增强对QoL的主观感受以及中重度OSA男性参与者的日间嗜睡情况。我们的假设是，tele-RHB计划与CPAP治疗相结合将通过改善OSA严重程度和上述参数而更有效。
这项随机对照试验旨在招募50名年龄在30至60岁之间新诊断为中重度OSA的男性参与者。参与者将按1:1随机分组，要么接受为期12周的tele-RHB计划并联合CPAP治疗，要么仅接受CPAP治疗。干预完成后，将邀请参与者完成1年的随访。主要结局将是AHI的多导睡眠图值、爱泼华嗜睡量表评分、36项简短健康调查（SF-36）评分、体脂百分比、6分钟步行试验覆盖距离以及最大吸气和呼气口腔压力值。次要结局将包括氧饱和度下降指数的多导睡眠图值、仰卧位AHI、总睡眠时间、平均心率、平均氧饱和度以及氧饱和度低于90%的时间百分比；颈部、腰围和臀围的人体测量；BMI值；用力肺活量；1秒用力呼气量；世界卫生组织的生活质量测量工具（WHOQOL-BREF）评分；以及血脂谱值。
研究招募于2021年10月25日开始，预计研究完成日期为2024年12月。将进行分析，以检验与单独的CPAP治疗相比，tele-RHB计划与CPAP治疗相结合在降低OSA严重程度以及改善QoL、身体成分和周长、运动耐量、血脂谱以及呼吸肌和肺功能方面是否更有效。
该研究将评估一项全面的tele-RHB计划对男性参与者上述选定参数的影响。这项干预的结果可能有助于进一步开发针对OSA的新型额外居家治疗选择。
ClinicalTrials.gov NCT04759456；https://clinicaltrials.gov/ct2/show/NCT04759456。
国际注册报告识别码（IRRID）：DERR1-10.2196/47460。
