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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of the State of Santa Catarina

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 volunteers

Qualifiers

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

Design model

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

10 Participants
are divided into 1 treatment group
Group A: Experimental Group: High-Intensity IMTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Secondary outcomes

1

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).
2

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).
3

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).
4

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).

Other outcomes

Sponsors and contacts

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