Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
NCT00660777 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2008-04-17
Summary
Background: Upper airway muscle weakness plays an important role in the genesis of obstructive sleep apnea (OSA). Oropharyngeal exercises are derived from speech therapy consisting of isometric and isotonic exercises directed to tongue, soft palate and lateral pharyngeal wall. We hypothesized that oropharyngeal exercises will attenuate OSA severity.
We will include 30 moderate OSA patients (apnea-hypopnea index (AHI), between 15 and 30 events/hour) that will randomize to 3 months of general measurements and daily nasal lavage (n=15, control) or daily oropharyngeal exercises (\~30 min) plus nasal lavage (n=16). Full polysomnography, anthropometric measurements, questionnaires derived from Berlin, Epworth and Pittsburgh evaluating quantitatively (range) snoring frequency (0-4) and intensity (1-3), daytime sleepiness (0-24) and sleep quality (0-21), respectively will be performed at baseline and study end.
Conditions
Interventions
- BEHAVIORAL
-
Deep breathing, bilateral alternate chewing, nasal lavage
Deep breathing, bilateral alternate chewing, nasal lavage
- BEHAVIORAL
-
Oropharyngeal exercises
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
Sponsors & Collaborators
-
Fundação de Amparo à Pesquisa do Estado de São Paulo
collaborator OTHER_GOV -
Conselho Nacional de Desenvolvimento Científico e Tecnológico
collaborator OTHER_GOV -
University of Sao Paulo
lead OTHER
Principal Investigators
-
Kátia Guimaraes · Heart Institute (InCor)
-
Geraldo Lorenzi-Filho, MD, PhD · Heart Institute (InCor)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 25 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-02-29
- Primary Completion
- 2007-10-31
- Completion
- 2008-04-30
Countries
- Brazil
Study Locations
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