Purpose

The aim of this study is to investigate the effect of comprehensive rehabilitation on apnea hypopnea index (AHI) in patients with obstructive sleep apnea (OSA).

Methods

Patients diagnosed with OSA and meeting the eligibility criteria will be randomly allocated in the groups. The experimental group will receive comprehensive rehabilitation, and the control group will receive myofunctional therapy. CPAP will be continued by all the participants. Both the groups will receive the interventions for 12 weeks. The primary outcome measures are AHI and Epworth Sleepiness Scale (ESS), and secondary outcomes are Pittsburg Sleep Quality Index (PSQI), Oxygen Desaturation Index (ODI), Snoring Index (SI), Manual Assessment of Respiratory Motion (MARM), Breath Hold Test (BHT), and Self Evaluation of Breathing Questionnaire (SEBQ). The outcomes will be assessed at baseline and at the end of 12 weeks. A follow-up will be taken at the end of 24 weeks. Power analysis suggests that enrollment of 118 patients will required. Repeated measures ANOVA will be used to analyze the effect of the intervention.

Conclusion

By performing this research, we may develop insights on a novel comprehensive approach for treatment of patients with OSA.

Trial registration

CTRI/2023/10/058486.

中文翻译：

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综合康复对阻塞性睡眠呼吸暂停患者呼吸暂停低通气指数的影响：随机对照试验方案

目的

本研究的目的是探讨综合康复对阻塞性睡眠呼吸暂停（OSA）患者呼吸暂停低通气指数（AHI）的影响。

方法

诊断为 OSA 并符合资格标准的患者将被随机分配到各组。实验组接受综合康复治疗,对照组接受肌功能治疗。所有参与者都将继续进行 CPAP 治疗。两组都将接受为期 12 周的干预措施。主要结果测量是 AHI 和 Epworth 嗜睡量表 (ESS)，次要结果是匹兹堡睡眠质量指数 (PSQI)、血氧饱和度指数 (ODI)、打鼾指数 (SI)、呼吸运动手动评估 (MARM)、屏气测试（BHT）和呼吸自我评估问卷（SEBQ）。结果将在基线和 12 周结束时进行评估。随访将在 24 周结束时进行。功效分析表明需要招募 118 名患者。重复测量方差分析将用于分析干预的效果。

结论

通过进行这项研究，我们可能会对治疗 OSA 患者的新型综合方法产生见解。

试用注册

CTRI/2023/10/058486。