Effects of inspiratory muscle training on the severity of obstructive sleep apnea in individuals after stroke: a protocol for a randomized controlled trial

Background Obstructive sleep apnea (OSA) is the most common form of sleep-disordered breathing in cerebrovascular diseases, requiring a multidisciplinary approach. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on apnea hypopnea index (AHI) reduction are controversial. Objective This protocol for a randomized clinical trial will assess the effects of IMT on the severity of obstructive sleep apnea, sleep quality, and daytime sleepiness in individuals after stroke participating in a rehabilitation program. Methods This study will be a randomized controlled trial with blinded assessors. Forty individuals after stroke will randomized to two groups. For 5 weeks, both groups will participate in the rehabilitation program activities, including aerobic exercise, resistance training, and educational class when they will receive guidance on the behavioral management of OSA. The experimental group will also perform high-intensity IMT 5 times a week, for 5 weeks, consisting initially of five sets of five repetitions achieving 75% of the maximal inspiratory pressure, increasing one set each week, totaling nine sets at the end of training. The primary outcome will be the severity of OSA measured as AHI at 5 weeks. Secondary outcomes will include sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) and daytime sleepiness measured by Epworth Sleepiness Scale (ESS). Outcomes will be collected by a researcher blinded to group allocation at baseline (week 0), after intervention (week 5), and 1 month beyond intervention (week 9). Trial registration Clinical Trials Register: NCT05135494.