Effectiveness of Inspiratory Muscle Training on Sleep in Patients With Obstructive Sleep Apnea

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What the trial wants to find out

The goal of this clinical trial is to evaluate the effectiveness of inspiratory Muscle Training (IMT) on both objective and subjective sleep parameters in patients with OSA.Methods: A prospective, randomized, controlled clinical trial will be conducted with patients diagnosed with OSA followed at Otavio de Freitas Hospital. Participants will be evaluated for excessive daytime sleepiness (Epworth Sleepiness Scale), sleep quality (Pittsburgh Sleep Quality Index), physical activity level (IPAQ), sleep latency, total sleep time, sleep efficiency, number of nocturnal awakenings, total time in bed, total wake time during sleep (Actigraphy), hypoxic burden during sleep (Nocturnal Oximetry), disease severity (Polysomnography), respiratory muscle strength (Manovacuometry), and respiratory muscle endurance (Powerbreathe K-series) before and after 4 weeks of training, as well as perceived change in health status after IMT (PGIC).Participants will be divided into two groups and will perform IMT for 4 weeks: the experimental group will perform IMT with a progressive weekly load (50%, 60%, 75% of MIP) adjusted using the Powerbreathe® Classic device, while the control group will use the device without load. The participants will perform IMT at home under the guidance of the principal investigator.Statistical Analysis: Data will be analyzed using SPSS version 26.0 with descriptive and analytical statistical techniques. Normality will be assessed using the Shapiro-Wilk test. For intergroup and intragroup comparisons, two-way ANOVA will be used. Tukey's post-hoc test will be applied to compare pre- and post-intervention mean variances for each group. The level of significance adopted for all analyses will be 95% (p < 0.05).Expected Results: It is expected that 4 weeks of IMT in patients with OSA will reduce excessive daytime sleepiness, sleep latency, number of awakenings, and hypoxic burden, as well as increase sleep efficiency and total sleep time, leading to improved sleep quality.

The 2 groups in the trial

• Group 1 - Inspiratory Muscle Training (IMT)Treatment being tested

  Participants with moderate to severe obstructive sleep apnea (OSA) will perform inspiratory muscle training using a threshold device with progressive loading over 4 weeks. Training will begin at 50% of maximal inspiratory pressure (MIP) for the first 2 weeks, increase to 60% in week 3, and 75% in week 4. Participants will perform three sets of 30 fast, forceful inspiratory efforts, with one-minute rest intervals between sets. Training sessions will occur twice daily, seven days per week. Load adjustments will be made weekly during in-person visits. Participants will record adherence and occurrences in a training diary and will be monitored daily by the principal investigator through phone calls.

  Treatment: Inspiratory Muscle Training

• Group 2 - Sham Inspiratory Muscle TrainingSham treatment, for comparison

  Participants in the control group will perform sham inspiratory muscle training using the same device with the internal spring removed, providing no resistance. The training protocol will mirror that of the intervention group: three sets of 30 fast inspiratory efforts, with one-minute rest intervals, performed twice daily, seven days per week, for 4 weeks. Weekly in-person visits will be held to verify procedures, and participants will log adherence in a training diary. Daily phone follow-ups will be conducted by the principal investigator.

  Treatment: Inspiratory Muscle Training