Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2004
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 7, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedApril 17, 2008
April 1, 2008
3.7 years
April 7, 2008
April 15, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea-hypopnea index
3 months
Secondary Outcomes (2)
Lowest oxygen saturation
3 months
Sleep related questionnaires
3 months
Study Arms (2)
1
SHAM COMPARATORControl Group
2
ACTIVE COMPARATORTherapy Group
Interventions
Deep breathing, bilateral alternate chewing, nasal lavage
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
Eligibility Criteria
You may qualify if:
- Patients aged between 25 and 65 years old with a recent diagnosis of moderate obstructive sleep apnea
You may not qualify if:
- Body mass index (BMI) \>40 kg/m2
- Facial malformations
- Regular use of hypnotic medications
- Hypothyroidism
- Previous stroke
- Neuromuscular disease
- Heart failure
- Coronary disease
- Severe obstructive nasal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Heart Institute (InCor)
São Paulo, São Paulo, 05403-904, Brazil
Related Publications (1)
Guimaraes KC, Drager LF, Genta PR, Marcondes BF, Lorenzi-Filho G. Effects of oropharyngeal exercises on patients with moderate obstructive sleep apnea syndrome. Am J Respir Crit Care Med. 2009 May 15;179(10):962-6. doi: 10.1164/rccm.200806-981OC. Epub 2009 Feb 20.
PMID: 19234106DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kátia Guimaraes
Heart Institute (InCor)
- PRINCIPAL INVESTIGATOR
Geraldo Lorenzi-Filho, MD, PhD
Heart Institute (InCor)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 7, 2008
First Posted
April 17, 2008
Study Start
February 1, 2004
Primary Completion
October 1, 2007
Study Completion
April 1, 2008
Last Updated
April 17, 2008
Record last verified: 2008-04