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Oropharyngeal Exercises and Post-Stroke Obstructive Sleep Apnea

NCT04212260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2023-04-14

No results posted yet for this study

Summary

This study evaluates the feasibility and effectiveness of an oropharyngeal exercise (O-PE) regimen in treating post-stroke obstructive sleep apnea, as an alternative therapy to continuous positive airway pressure (CPAP). Eligible patients will be randomized (1:1) to treatment using a pre-specified schedule of O-PEs vs. a sham control arm.

Conditions

  • Apnea
  • Sleep Apnea Syndromes
  • Sleep Apnea, Obstructive
  • Stroke
  • Transient Ischemic Attack

Interventions

BEHAVIORAL

Oropharyngeal exercises

Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.

BEHAVIORAL

Sham control

Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.

Sponsors & Collaborators

  • Toronto Rehabilitation Institute

    collaborator OTHER

  • University of Toronto

    collaborator OTHER

  • Unity Health Toronto

    collaborator OTHER

  • Sunnybrook Research Institute

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Mark Boulos, MD MSc FRCPC · Sunnybrook Health Sciences Centre

  • Yana Yunusova, MSc PhD · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2022-12-09
Completion
2022-12-09

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212260 on ClinicalTrials.gov