Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Deep breathing, bilateral alternate chewing, nasal lavage
Oropharyngeal exercises
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring oropharyngeal exercises, obstructive sleep apnea, speech therapy
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 25 and 65 years old with a recent diagnosis of moderate obstructive sleep apnea
Exclusion Criteria:
- 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
Sites / Locations
- Heart Institute (InCor)
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
1
2
Arm Description
Control Group
Therapy Group
Outcomes
Primary Outcome Measures
Apnea-hypopnea index
Secondary Outcome Measures
Lowest oxygen saturation
Sleep related questionnaires
Full Information
NCT ID
NCT00660777
First Posted
April 7, 2008
Last Updated
April 15, 2008
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
1. Study Identification
Unique Protocol Identification Number
NCT00660777
Brief Title
Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
Official Title
Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea: A Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Patients: Eligible patients aged between 25 e 65 years old with a recent diagnosis of moderate OSA evaluated in the sleep laboratory, Pulmonary Division, Heart Institute (InCor). We will exclude patients with one or more of the follow conditions: body mass index (BMI) >40 kg/m2; facial malformations; regular use of hypnotic medications, hypothyroidism, previous stroke, neuromuscular disease, heart failure, coronary disease, and severe obstructive nasal disease.
Polysomnography: All patients will be evaluated by full polysomnography. The person who analyzed the sleep study will be blind to the group allocation.
Questionnaire: We will employ questionnaires previously validated and used in Brazil: Snoring frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire).
Control Group: Sham therapy will consisted of a weekly supervised section (~30 min) of deep breathing, through the nose, while sitting, followed by a practice of bilateral alternate chewing. The patients will be instructed to perform the same procedure at home once a day (30 min), plus alternate bilateral chewing and nasal lavage with application of 10 ml of saline in each nostril three times a day.
Study Group: The same schedule and set of instructions will be applied to the control group was given to these patients. Oropharyngeal exercises are derived from speech language pathology and include soft palate, tongue and facial muscles exercises as well as stomatognathic function exercises.
Experimental Design: After fulfilling entry criteria, the patients will be randomized for 3 months of control or treatment group, with oropharyngeal exercises. All patients will be evaluated by the speech language pathologist once a week for 30 minutes. Patients that failed to return for 3 consecutive weeks or failed to comply to the exercises schedule at home were excluded from the study. Polysomnography and questionnaires will be performed at the beginning and at the end of the study.
Primary outcome: Apnea-hypopnea index.
Secondary outcomes: Lowest oxygen saturation and sleep related questionnaires.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
oropharyngeal exercises, obstructive sleep apnea, speech therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Sham Comparator
Arm Description
Control Group
Arm Title
2
Arm Type
Active Comparator
Arm Description
Therapy Group
Intervention Type
Behavioral
Intervention Name(s)
Deep breathing, bilateral alternate chewing, nasal lavage
Intervention Description
Deep breathing, bilateral alternate chewing, nasal lavage
Intervention Type
Behavioral
Intervention Name(s)
Oropharyngeal exercises
Intervention Description
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
Primary Outcome Measure Information:
Title
Apnea-hypopnea index
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Lowest oxygen saturation
Time Frame
3 months
Title
Sleep related questionnaires
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged between 25 and 65 years old with a recent diagnosis of moderate obstructive sleep apnea
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kátia Guimaraes
Organizational Affiliation
Heart Institute (InCor)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Geraldo Lorenzi-Filho, MD, PhD
Organizational Affiliation
Heart Institute (InCor)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Institute (InCor)
City
Sao Paulo
ZIP/Postal Code
05403-904
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
19234106
Citation
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.
Results Reference
derived
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Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
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