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

Summary

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.

Conditions

• Obstructive Sleep Apnea (OSA)
• Sleep

Interventions

DEVICE

Inspiratory Muscle Training

Inspiratory muscle training (IMT) was performed for 4 weeks in patients with moderate to severe OSA. The intervention group used a threshold device with resistance: training occurred twice daily, 7 days per week, with 3 sets of 30 fast inspiratory efforts and 1-minute rest between sets. Load started at 50% of maximal inspiratory pressure (MIP), increased to 60% in week 3, and 75% in week 4. Weekly visits were held for load adjustment. The sham group followed the same schedule using the same device without resistance (spring removed). Both groups recorded adherence in training diaries and received daily follow-up calls from the principal investigator

Sponsors & Collaborators

• Universidade Federal de Pernambuco

  lead OTHER

Principal Investigators

• Armele D de Andrade, PhD Pneumo · Universidade Federal de Pernambuco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-11

Primary Completion

2025-12-20

Completion

2026-02-20

Countries

• Brazil

Study Locations