Effects of Inspiratory Muscle Training on the Severity of Obstructive Sleep Apnea in Individuals After Stroke

NCT05135494 | Completed DMC

• 1 other identifier: 47173121.0.0000.0022
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Stroke; Obstructive Sleep Apnea; Inspiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

• OSA severity

  OSA severity measured using the Apnea/Hypopnea Index (AHI)

  5 weeks (immediately post intervention)

Secondary Outcomes (4)

• inspiratory muscle endurance

  5 weeks (immediately post intervention)

• inspiratory muscular strength

  5 weeks (immediately post intervention)

• sleep quality

  1 month post intervention

• daytime sleepiness

  1 month post intervention

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental Group: Inspiratory Muscle Training + rehabilitation program

Other: Inspiratory Muscle Training

Control Group

OTHER

Control Group: rehabilitation program

Other: Control

Interventions

Inspiratory Muscle Training OTHER

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.

Experimental Group

Control OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarah Network of Rehabilitation Hospitals: lead

Study Sites (1)

Lorena de Oliveira Vaz

Salvador, Brazil

Location

Related Publications (1)

• 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.

  PMID: 37103682 DERIVED

MeSH Terms

Conditions

Stroke; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigatot

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: November 26, 2021
• Study Start: November 30, 2021
• Primary Completion: November 27, 2023
• Study Completion: December 30, 2023
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)