Obesity, Class IIINCT07469280
High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea
A study testing High-Intensity Progressive Inspiratory Muscle Training (IMT) in people with Obesity, Class III and Sleep Apnea, Obstructive, run by University of the State of Santa Catarina at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Class III, Sleep Apnea, Obstructive, Inspiratory Muscle Training
- What is being tested?
- High-Intensity Progressive Inspiratory Muscle Training (IMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Santa Catarina State University - CEFID (Center of Health and Sport Sciences)
Florianópolis, Santa Catarina, 88080-350
Karina Abreu, MSc, +55 (48) 3664-8651, karina.abreu1@edu.udesc.br
About this study
Official title: High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea: Study Protocol for a Prospective Nonconcurrent Multiple-Baseline Single-Case Experimental Design With Stability-Based Phase Transition
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.
- Being tested
- High-Intensity Progressive Inspiratory Muscle Training (IMT)
- Keywords
- Class III obesity, Inspiratory muscle training, Obstructive sleep apnea, Single-case experimental design
- Medical subject headings
- Obesity, Sleep Apnea, Obstructive, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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."
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: High-Intensity IMT | Experimental | Participants will undergo a progressive high-intensity Inspiratory Muscle Training (IMT) program using a resistive loading device (POWERbreathe). Receives: Device: High-Intensity Progressive Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
Number of apnea and hypopnea events per hour of sleep, measured via portable polygraphy (Type III)
Measured: Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week).
Secondary outcomes (6)
Maximum Inspiratory Pressure (MIP)
Assessment of inspiratory muscle strength using a digital pressure manometer.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline (Phase A) and Post-Intervention (12th week of Phase B).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the State of Santa Catarina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karina Abreu, University of the State of Santa Catarina
- Investigators
- Darlan Laurício Matte, PhD, Study chair, Santa Catarina State University (UDESC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469280
- Sponsor's protocol ID
- CAAE86299625.1.0000.0118
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 36419804
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Progressive Inspiratory Muscle Training in Class III Obesity and Obstructive Sleep Apnea: Study Protocol for a Prospective Nonconcurrent Multiple-Baseline Single-Case Experimental Design With Stability-Based Phase Transition
- ClinicalTrials.gov ID
- NCT07469280
- Acronym / sponsor ID
- CAAE86299625.1.0000.0118
- Keywords
- Class III obesity, Inspiratory muscle training, Obstructive sleep apnea, Single-case experimental design
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of the State of Santa CatarinaUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: High-Intensity IMT | Experimental | Device: High-Intensity Progressive Inspiratory Muscle Training (IMT)Participants will undergo a progressive high-intensity Inspiratory Muscle Training (IMT) program using a resistive loading device (POWERbreathe). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Progressive Inspiratory Muscle Training (IMT)"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." | Device | Experimental Group: High-Intensity IMT |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 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)
6 secondary outcomes
Maximum Inspiratory Pressure (MIP)
Time frame: Weekly assessments throughout Phase A (3 to 5 weeks) and Phase B (12 weeks).
Epworth Sleepiness Scale (ESS) score
Time frame: Baseline and Post-Intervention (12th week).
Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Baseline and Post-Intervention (12th week).
International Physical Activity Questionnaire (IPAQ) - Short Form
Time frame: Baseline and Post-Intervention (12th week).
Borg Rating of Perceived Exertion (RPE)
Time frame: Daily during the 12 weeks of intervention (Phase B).
Quebec Sleep Questionnaire (QSQ)
Time frame: Baseline (Phase A) and Post-Intervention (12th week of Phase B).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- BackgroundGRANVILE, 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: PubMed 36419804Dar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Darlan Laurício Matte, PhD study chair
Santa Catarina State University (UDESC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Intensity Progressive Inspiratory Muscle Training (IMT) in people with Obesity, Class III and Sleep Apnea, Obstructive, run by University of the State of Santa Catarina at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karina Abreu, MSc (+55 (48) 998230417, fisioterapeutakarina.abreu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: Baseline (Phase A - three measurements) and Post-Intervention (Phase B - 12th week).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07469280, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.