Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive

Study Overview
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Brief Summary
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Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.

Detailed Description
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This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.

Official Title
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Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea

Conditions
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Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).

Intervention / Treatment
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* Behavioral: Oropharyngeal exercises
* Behavioral: Respiratory exercises, nasal dilator, nasal lavage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects with primary snore, mild and moderate obstructive sleep apnea Exclusion Criteria: BMI > or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oropharyngeal exercises and oropharyngeal functions | Behavioral: Oropharyngeal exercises<br>* Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.<br>|
| Sham Comparator: 2<br>Nasal dilator, respiratory exercise, nasal lavage | Behavioral: Respiratory exercises, nasal dilator, nasal lavage<br>* Respiratory exercises, nasal dilator, nasal lavage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper airway collapsability |  | 3 months | 
| Images from magnetic resonance |  | 3 months | 
| Negative expiratory pressure |  | 3 months | 
| Snore |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep related questionnaires |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore