Sleep & breathing = Schlaf & Atmung · 2023
Effect of comprehensive rehabilitation on apnea hypopnea index in patients with obstructive sleep apnea: a protocol for randomized controlled trial.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Pawar Mrudula, Venkatesan Prem, Mysore Satyanarayana, Bhat Guruprasad
Аннотация
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.
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.