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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
"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."
Santa Catarina State University - CEFID (Center of Health and Sport Sciences)
Florianópolis, Santa Catarina, Brazil
Apnea-Hypopnea Index (AHI)
Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III)
Time frame: Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week).
Maximum Inspiratory Pressure (MIP)
Assessment of inspiratory muscle strength using a digital pressure manometer.
Time frame: Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks).
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.
Time frame: Baseline and Post-Intervention (12th week).
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.
Time frame: Baseline and Post-Intervention (12th week).
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).
Time frame: Baseline and Post-Intervention (12th week).
Borg Rating of Perceived Exertion (RPE)
Scale ranging from 6 to 20 used to monitor the intensity of the respiratory effort during the IMT sessions.
Time frame: Daily during the 12 weeks of intervention (Phase B).
Quebec Sleep Questionnaire (QSQ)
A disease-specific quality of life questionnaire for obstructive sleep apnea. It consists of 32 items divided into five domains: daytime sleepiness, diurnal symptoms, nocturnal symptoms, emotions, and social interactions. Each item is scored on a 7-point Likert scale, where higher scores indicate better quality of life.
Time frame: Baseline (Phase A) and Post-Intervention (12th week of Phase B).
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