Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
NCT ID: NCT01289405
Last Updated: 2014-02-06
Study Results
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Basic Information
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COMPLETED
NA
80 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo exercices
relaxation exercises and stretching neck, without therapeutic purpose.
Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
phonoaudiologic therapy
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.
Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
Interventions
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Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) \< 35 kg/m2
Exclusion Criteria
* Regular use of hypnotic medications
* Hypothyroidism
* Previous stroke
* Neuromuscular disease
* Heart failure
* Coronary disease
* Severe obstructive nasal disease
25 Years
65 Years
MALE
No
Sponsors
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Associação Fundo de Incentivo à Pesquisa
OTHER
Responsible Party
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Prof. Dr. Lia Azeredo-Bittencourt
professor
Principal Investigators
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Lia Rita A Bittencourt, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal de São Paulo
Locations
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Associação Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo, Brazil
Countries
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References
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Diaferia G, Santos-Silva R, Truksinas E, Haddad FLM, Santos R, Bommarito S, Gregorio LC, Tufik S, Bittencourt L. Myofunctional therapy improves adherence to continuous positive airway pressure treatment. Sleep Breath. 2017 May;21(2):387-395. doi: 10.1007/s11325-016-1429-6. Epub 2016 Dec 2.
Other Identifiers
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CEP 2002/08
Identifier Type: -
Identifier Source: org_study_id
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