About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Of both genders.
Class III obesity (BMI > 40 kg/m²).
Diagnosis of OSA.
Without neurological conditions that would prevent them from responding to the study assessments.
Disqualifiers
Systemic diseases (pulmonary, cardiac or renal).
Are using medications that may affect muscle performance.
Are currently using CPAP therapy.
Conditions that could compromise adherence to the study protocol.
Trial design
Single group
Treatments tested in this trial
High-Intensity Progressive Inspiratory Muscle Training (IMT)
Device"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."
Treatment groups
Trial outcomes
Primary outcomes
Apnea-Hypopnea Index (AHI)
Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III)
Secondary outcomes
Maximum Inspiratory Pressure (MIP)
Assessment of inspiratory muscle strength using a digital pressure manometer.
Epworth Sleepiness Scale (ESS) score
Validated questionnaire to assess the level of daytime sleepiness. Scores range from 0 to 24, where higher scores indicate greater sleepiness.
Pittsburgh Sleep Quality Index (PSQI) global score
Questionnaire to assess sleep quality over a one-month period. Scores range from 0 to 21; higher scores indicate poorer sleep quality.
International Physical Activity Questionnaire (IPAQ) - Short Form
Assessment of physical activity level. It classifies participants as sedentary, irregularly active, active, or very active based on metabolic equivalent task (MET-min/week).
Sponsors and contacts
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