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

NCT07469280 | Not Yet Recruiting

• 1 other identifier: CAAE86299625.1.0000.0118
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Class III obesity; Inspiratory muscle training; Obstructive sleep apnea; Single-case experimental design

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI)

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

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

Secondary Outcomes (6)

• Maximum Inspiratory Pressure (MIP)

  Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks).

• Epworth Sleepiness Scale (ESS) score

  Baseline and Post-Intervention (12th week).

• Pittsburgh Sleep Quality Index (PSQI) global score

  Baseline and Post-Intervention (12th week).

• International Physical Activity Questionnaire (IPAQ) - Short Form

  Baseline and Post-Intervention (12th week).

• Borg Rating of Perceived Exertion (RPE)

  Daily during the 12 weeks of intervention (Phase B).

Study Arms (1)

Experimental Group: High-Intensity IMT

EXPERIMENTAL

Participants will undergo a progressive high-intensity Inspiratory Muscle Training (IMT) program using a resistive loading device (POWERbreathe).

Device: High-Intensity Progressive Inspiratory Muscle Training (IMT)

Interventions

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."

Experimental Group: High-Intensity IMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of the State of Santa Catarina: lead

Study Sites (1)

Santa Catarina State University - CEFID (Center of Health and Sport Sciences)

Florianópolis, Santa Catarina, 88080-350, Brazil

Location

Related Publications (2)

• GRANVILE, A. A. B. B.; BORGES, A. C. L.; RUAS, G. EFEITOS DO TREINAMENTO DE ALTA E BAIXA INTENSIDADE NA MUSCULATURA INSPIRATÓRIA EM INDIVÍDUOS OBESOS MÓRBIDOS: ESTUDO RANDOMIZADO CONTROLADO. Revista Brasileira de Obesidade, Nutrição e Emagrecimento, p. 469-478, dez. 2017.

  BACKGROUND

• Dar JA, Mujaddadi A, Moiz JA. Effects of inspiratory muscle training in patients with obstructive sleep apnoea syndrome: a systematic review and meta-analysis. Sleep Sci. 2022 Oct-Dec;15(4):480-489. doi: 10.5935/1984-0063.20220081.

  PMID: 36419804 BACKGROUND

MeSH Terms

Conditions

Obesity; Sleep Apnea, Obstructive; Obesity, Morbid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Darlan Laurício Matte, PhD

  Santa Catarina State University (UDESC)

  STUDY CHAIR

Central Study Contacts

Karina Abreu, MSc

CONTACT

+55 (48) 998230417; fisioterapeutakarina.abreu@gmail.com

Darlan Laurício Matte, PhD

CONTACT

+55 48 3364 8696; darlan.matte@udesc.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study utilizes a prospective, non-concurrent multiple-baseline single-case experimental design (SCED) with stability-based phase transition. The protocol is divided into Phase A (Baseline) and Phase B (Intervention), where the start of the high-intensity inspiratory muscle training is determined by the stability of the primary outcomes during the baseline period.

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)