NCT05135494

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

Completed NA Last updated 22 April 2024

What this trial tests

NA trial testing Inspiratory Muscle Training in Stroke in 41 participants. Completed in 30 December 2023.

Timeline

30 November 2021

Primary endpoint
27 November 2023

30 December 2023

Quick facts

Lead sponsor	Sarah Network of Rehabilitation Hospitals
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	41
Start date	30 November 2021
Primary completion	27 November 2023
Estimated completion	30 December 2023
Sites	1 location across Brazil

Drugs / interventions tested

• Inspiratory Muscle Training
• Control

Conditions studied

• Stroke — all drugs for Stroke →
• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Inspiratory Muscle Training — all drugs for Inspiratory Muscle Training →

Sponsor

Sarah Network of Rehabilitation Hospitals

Who can join

Adults 18 to 80, any sex, with Stroke or Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of inspiratory muscle training on the severity of obstructive sleep apnea in individuals after stroke: a protocol for a randomized controlled trial.
   de Oliveira Vaz L, Galvão AP, Nunes DLM, de Almeida JC, et al · · 2023 · PMID 37103682 · DOI 10.1007/s11325-023-02825-0