Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Device: Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT01289405
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-02
• Study First Posted: 2011-02-03
• Primary Completion: 2011-12
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-05
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo exercices	Continuous Positive Airway Pressure (CPAP)	relaxation exercises and stretching neck, without therapeutic purpose.
phonoaudiologic therapy	Continuous Positive Airway Pressure (CPAP)	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.

Primary Outcome Measures

Name	Time	Method
objective sleep pattern	90 days	sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography

Secondary Outcome Measures

Name	Time	Method
somnolence	90 days	score of Epworth Sleepiness Scale
Quality of Life	90 days	score of WHOQOL-BREF and FOSQ questionnaires
Cognition	90 days	Evaluations of Psychomotor Vigilance Test

Trial Locations

Locations (1)

Associação Fundo de Incentivo a Psicofarmacologia; 🇧🇷 São Paulo, SP, Brazil