StrokeNCT05135494
Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke
A study testing Inspiratory Muscle Training in people with Stroke and Obstructive Sleep Apnea, run by Sarah Network of Rehabilitation Hospitals at 1 site in Brazil.
Trial summary
The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Obstructive Sleep Apnea, Inspiratory Muscle Training
- What is being tested?
- Inspiratory Muscle Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Nov 2021to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals after stroke of any etiology (ischemic or hemorrhagic), 18 to 80 years age, in a subacute or chronic phase (over 3 months to 5 years); with a diagnosis of OSA, defined as increased AHI (>5/h) in a polysomnography exam.
Who cannot join
- Individuals with BMI > 40, using Positive Airway Pressure during sleep, severe OSA (AHI > 30), previous diagnosis of severe nasal obstructive disease; craniofacial malformations including signs of dentoskeletal deformities, history of pharyngeal surgery to treat apnea, palatine tonsil hypertrophy (grade III and IV); edentulous people or users of complete dental prostheses; presence of oral apraxia; facial paralysis that prevents lip occlusion; aphasia that compromises the understanding of verbal commands; smokers and former smokers with less than 6 months of smoking cessation, orthopedic changes that include distortions of the rib cage and lung parenchyma diseases and that present other associated neurological diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke: a Randomized and Controlled Clinical Trial
The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial.
This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA, sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program.
Read more
Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
Read the detailed description
The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. The gold standard treatment for OSA is the use of Positive Airway Pressure, but due to the low adherence to this resource, the multidisciplinary approach for the treatment of OSA is becoming the best therapeutic option. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial.
Aims:The primary objective of this study is to identify the effects of IMT on the severity of OSA in indivuals after stroke participating in a rehabilitation program. The secondary objectives are to identify effects of IMT on sleep quality and daytime sleepiness and analyze the correlation between severity of OSA and functional independence, inspiratory endurance and pressure.
Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
- Conditions
- Stroke, Obstructive Sleep Apnea, Inspiratory Muscle Training
- Being tested
- Inspiratory Muscle Training, Control
- Medical subject headings
- Stroke, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingOther
The Experimental Group will perform IMT which includes training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week.
They will participate of the rehabilitation program that will consist of an average of 8 weekly sessions of physiotherapy and speech therapy, totaling 40 sessions. They will also perform 150 to 180 minutes of aerobic exercise of their choice and guidance on behavioral measures to manage OSA.
ControlOther
The control group will participate of the rehabilitation program that will consist of an average of 8 weekly sessions of physiotherapy and speech therapy, totaling 40 sessions. They will also perform 150 to 180 minutes of aerobic exercise of their choice and guidance on behavioral measures to manage OSA.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental Group: Inspiratory Muscle Training + rehabilitation program Receives: Other: Inspiratory Muscle Training |
| Control Group | Other | Control Group: rehabilitation program Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSA severity
OSA severity measured using the Apnea/Hypopnea Index (AHI)
Measured: 5 weeks (immediately post intervention)
Secondary outcomes (4)
inspiratory muscle endurance
inspiratory muscle endurance measured through the incremental endurance test
Measured: 5 weeks (immediately post intervention)
inspiratory muscular strength
inspiratory muscular strength measured through inspiratory pressures
Measured: 5 weeks (immediately post intervention)
sleep quality
sleep quality measered through Pittisburgh Sleep Quality Index
Measured: 1 month post intervention
daytime sleepiness
daytime sleepiness measered through Epworth Sleepiness Scale
Measured: 1 month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start30 Nov 2021
- Primary completion27 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Network of Rehabilitation Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorena de Oliveira Vaz Miranda, Sarah Network of Rehabilitation Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135494
- Sponsor's protocol ID
- 47173121.0.0000.0022
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Oliveira Vaz L, Galvao AP, Nunes DLM, de Almeida JC, de Fatima Garcia Diniz J, Oliveira-Filho J. Effects of inspiratory muscle training on the severity of obstructive sleep apnea in individuals after stroke: a protocol for a randomized controlled trial. Sleep Breath. 2023 Dec;27(6):2257-2263. doi: 10.1007/s11325-023-02825-0. Epub 2023 Apr 27.
PubMed 37103682
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke: a Randomized and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05135494
- Acronym / sponsor ID
- 47173121.0.0000.0022
- Conditions
- Stroke, Obstructive Sleep Apnea, Inspiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Sarah Network of Rehabilitation HospitalsUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 26 Nov 2021 (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 prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial.
This study will test the hypothesis that training of the inspiratory muscles is effective in improving severity of OSA, sleep quality and daytime sleepiness in individuals after stroke participating in a rehabilitation program.
Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
Detailed description
The prevalence of Obstructive Sleep Apnea (OSA) is high in individuals after a stroke. The gold standard treatment for OSA is the use of Positive Airway Pressure, but due to the low adherence to this resource, the multidisciplinary approach for the treatment of OSA is becoming the best therapeutic option. There are few studies evaluating the effects of inspiratory muscle training (IMT) in individuals with OSA and the findings regarding the possible effect on Apneia/Hipopneia Index (AHI) reduction are still controversial.
Aims:The primary objective of this study is to identify the effects of IMT on the severity of OSA in indivuals after stroke participating in a rehabilitation program. The secondary objectives are to identify effects of IMT on sleep quality and daytime sleepiness and analyze the correlation between severity of OSA and functional independence, inspiratory endurance and pressure.
Methods: For this prospective, sigle blinded, randomized clinical trial, people after stroke will be randomly allocated into either experimental or control groups. The experimental group will undertake training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. Both groups will participate in the rehabilitation program and will receive the same dose of physiotherapy, speech therapy and aerobic exercise sessions. At baseline and post intervention after the cessation of the interventions, researchers blinded to group allocations will collect all outcome measures.
Study outcomes: Primary outcome will be OSA severity measured using the Apnea/Hypopnea Index (AHI). Secondary outcomes will include inspiratory endurance and pressure, functional independence, sleep quality and daytime sleepiness
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Inspiratory Muscle TrainingExperimental Group: Inspiratory Muscle Training + rehabilitation program |
| Control Group | Other | Other: ControlControl Group: rehabilitation program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals after stroke of any etiology (ischemic or hemorrhagic), 18 to 80 years age, in a subacute or chronic phase (over 3 months to 5 years); with a diagnosis of OSA, defined as increased AHI (>5/h) in a polysomnography exam.
Key exclusion criteria (1 listed)
- Individuals with BMI > 40, using Positive Airway Pressure during sleep, severe OSA (AHI > 30), previous diagnosis of severe nasal obstructive disease; craniofacial malformations including signs of dentoskeletal deformities, history of pharyngeal surgery to treat apnea, palatine tonsil hypertrophy (grade III and IV); edentulous people or users of complete dental prostheses; presence of oral apraxia; facial paralysis that prevents lip occlusion; aphasia that compromises the understanding of verbal commands; smokers and former smokers with less than 6 months of smoking cessation, orthopedic changes that include distortions of the rib cage and lung parenchyma diseases and that present other associated neurological diseases.
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 |
|---|---|---|
| Inspiratory Muscle TrainingThe Experimental Group will perform IMT which includes training of the inspiratory muscles with the PowerBreath Medic Plus regulated at 75% of the subjects' maximal inspiratory pressure (MIP) values, five times/week over five weeks 5 sets of 5 repetitions with 1 set increasing each week. They will participate of the rehabilitation program that will consist of an average of 8 weekly sessions of physiotherapy and speech therapy, totaling 40 sessions. They will also perform 150 to 180 minutes of aerobic exercise of their choice and guidance on behavioral measures to manage OSA. | Other | Experimental Group |
| ControlThe control group will participate of the rehabilitation program that will consist of an average of 8 weekly sessions of physiotherapy and speech therapy, totaling 40 sessions. They will also perform 150 to 180 minutes of aerobic exercise of their choice and guidance on behavioral measures to manage OSA. | Other | Control Group |
Primary outcome
OSA severity
Time frame: 5 weeks (immediately post intervention)
OSA severity measured using the Apnea/Hypopnea Index (AHI)
4 secondary outcomes
inspiratory muscle endurance
Time frame: 5 weeks (immediately post intervention)
inspiratory muscular strength
Time frame: 5 weeks (immediately post intervention)
sleep quality
Time frame: 1 month post intervention
daytime sleepiness
Time frame: 1 month post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 37103682de Oliveira Vaz L, Galvao AP, Nunes DLM, de Almeida JC, de Fatima Garcia Diniz J, Oliveira-Filho J. Effects of inspiratory muscle training on the severity of obstructive sleep apnea in individuals after stroke: a protocol for a randomized controlled trial. Sleep Breath. 2023 Dec;27(6):2257-2263. doi: 10.1007/s11325-023-02825-0. Epub 2023 Apr 27.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Stroke and Obstructive Sleep Apnea, run by Sarah Network of Rehabilitation Hospitals 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSA severity (time frame: 5 weeks (immediately post intervention)). 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 NCT05135494, which also lists 1 linked publication.
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 22 Apr 2024.