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| Sponsors and Collaborators: |
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo CNPq |
|---|---|
| Information provided by: | University of Sao Paulo |
| ClinicalTrials.gov Identifier: | NCT00660777 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Behavioral: Deep breathing, bilateral alternate chewing, nasal lavage Behavioral: Oropharyngeal exercises |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea: A Randomized, Controlled Study |
| Enrollment: | 30 |
| Study Start Date: | February 2004 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Sham Comparator
Control Group
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Behavioral: Deep breathing, bilateral alternate chewing, nasal lavage
Deep breathing, bilateral alternate chewing, nasal lavage
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2: Active Comparator
Therapy Group
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Behavioral: Oropharyngeal exercises
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
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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.
Eligibility| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil | |
| Heart Institute (InCor) | |
| Sao Paulo, Brazil, 05403-904 | |
| Principal Investigator: | Kátia Guimaraes | Heart Institute (InCor) |
| Principal Investigator: | Geraldo Lorenzi-Filho, MD, PhD | Heart Institute (InCor) |
More Information
| Responsible Party: | Heart Institute (InCor) - University of Sao Paulo Medical School ( Geraldo Lorenzi-Filho ) |
| Study ID Numbers: | OPE-OSA |
| Study First Received: | April 7, 2008 |
| Last Updated: | April 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00660777 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
|
oropharyngeal exercises obstructive sleep apnea speech therapy |
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Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders Sleep Apnea, Obstructive |
Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic Communication Disorders |
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Nervous System Diseases |
