NCT07469280

High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea

High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea: Study Protocol for a Prospective Nonconcurrent Multiple-Baseline Single-Case Experimental Design With Stability-Based Phase Transition

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of the State of Santa Catarina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the feasibility and effects of a 12-week high-intensity progressive Inspiratory Muscle Training (IMT) program in individuals with Class III obesity (BMI ≥ 40 kg/m²) and obstructive sleep apnea (OSA). Using a single-case experimental design (SCED) with multiple baselines, the study will investigate whether this respiratory intervention can reduce the severity of sleep apnea, as measured by the Apnea-Hypopnea Index (AHI), and improve inspiratory muscle strength and sleep quality. Participants will perform daily training sessions using a resistive loading device (POWERbreathe), with intensity progressing from 40% to 90% of their maximum inspiratory pressure.

Conditions

• Obesity, Class III
• Sleep Apnea, Obstructive
• Inspiratory Muscle Training

Interventions

Type	Name	Description
DEVICE	High-Intensity Progressive Inspiratory Muscle Training (IMT)	"The intervention consists of 12 weeks of inspiratory muscle training performed 5 days per week. Each session includes 30 breaths through a resistive loading device (POWERbreathe). The training intensity starts at 40% of the Maximum Inspiratory Pressure (MIP) and progressively increases to 90% of MIP. Training load is adjusted weekly based on new MIP measurements to ensure high-intensity stimulus. Compliance and adverse events will be monitored through a training diary."

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-05-01
• Completion: 2027-12-01
• First posted: 2026-03-13
• Last updated: 2026-03-23

Locations

1 site across 1 country: Brazil