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

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.

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 Overview

• Status: Completed
• Conditions: Stroke; Obstructive Sleep Apnea; Inspiratory Muscle Training
• Intervention / Treatment: Other: Inspiratory Muscle Training; Other: Control

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Salvador, Brazil
    • Lorena de Oliveira Vaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Experimental Group: Inspiratory Muscle Training + rehabilitation program	Other: Inspiratory Muscle Training; 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.
Other: Control Group; Control Group: rehabilitation program	Other: Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSA severity	OSA severity measured using the Apnea/Hypopnea Index (AHI)	5 weeks (immediately post intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inspiratory muscle endurance	inspiratory muscle endurance measured through the incremental endurance test	5 weeks (immediately post intervention)
inspiratory muscular strength	inspiratory muscular strength measured through inspiratory pressures	5 weeks (immediately post intervention)
sleep quality	sleep quality measered through Pittisburgh Sleep Quality Index	1 month post intervention
daytime sleepiness	daytime sleepiness measered through Epworth Sleepiness Scale	1 month post intervention

Collaborators and Investigators

• Sponsor: Sarah Network of Rehabilitation Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): November 27, 2023
• Study Completion (Actual): December 30, 2023

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): November 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Stroke; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Apnea
• Other Study ID Numbers: 47173121.0.0000.0022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No