Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07469280

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity, Class III, Sleep Apnea, Obstructive, Inspiratory Muscle Training

Full registry criteria

Inclusion Criteria: -Adults (≥18 years). * 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. Exclusion Criteria: * 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.

Treatments and study arms

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."

Primary outcomes

Apnea-Hypopnea Index (AHI)Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week).

Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Santa Catarina State University - CEFID (Center of Health and Sport Sciences)🇧🇷 Florianópolis, Santa Catarina, Brazil

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Karina Abreu, MScContact

Email · Call +55 (48) 3664-8651