Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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Objective: to evaluate the effects of a speech therapy exercises program in the treatment of Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography (PSG) parameters. Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index < 35 kg/m2 and scores of Epworth Sleepiness Scale > 9. Patients will be divided into four groups: I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or placebo. The speech therapy include isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck, without therapeutic purpose. Both therapies are applied for three months, three times a day, lasting 20 minutes each session. During the treatment, the subjects will be monitored in weekly meetings, for orientation and description of the exercises and return of the fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns after one week, a month and at the end of the study. Conduct assessments before and after treatment and after twenty one days washout, including: assessing the upper airway, anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor Vigilance Test and PSG.

Official Title
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Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome

Conditions
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Obstructive Sleep Apnea Syndrome

Intervention / Treatment
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* Device: Continuous Positive Airway Pressure (CPAP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a recent diagnosis of OSAS Body mass index (BMI) < 35 kg/m2 Exclusion Criteria: Facial malformations Regular use of hypnotic medications Hypothyroidism Previous stroke Neuromuscular disease Heart failure Coronary disease Severe obstructive nasal disease

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

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo exercices<br>relaxation exercises and stretching neck, without therapeutic purpose. | Device: Continuous Positive Airway Pressure (CPAP)<br>* mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea<br>|
| Active Comparator: phonoaudiologic therapy<br>isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. | Device: Continuous Positive Airway Pressure (CPAP)<br>* mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective sleep pattern | sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| somnolence | score of Epworth Sleepiness Scale | 90 days | 
| Quality of Life | score of WHOQOL-BREF and FOSQ questionnaires | 90 days | 
| Cognition | Evaluations of Psychomotor Vigilance Test | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obstructive sleep apnea, oropharyngeal exercises, speech therapy