Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea Syndrome |
Device: Continuous Positive Airway Pressure (CPAP) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome |
- objective sleep pattern [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography
- somnolence [ Time Frame: 90 days ] [ Designated as safety issue: No ]score of Epworth Sleepiness Scale
- Quality of Life [ Time Frame: 90 days ] [ Designated as safety issue: No ]score of WHOQOL-BREF and FOSQ questionnaires
- Cognition [ Time Frame: 90 days ] [ Designated as safety issue: No ]Evaluations of Psychomotor Vigilance Test
| Estimated Enrollment: | 80 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: placebo exercices
relaxation exercises and stretching neck, without therapeutic purpose.
|
Device: Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
|
|
Active Comparator: 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.
|
Device: Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
|
Eligibility| Ages Eligible for Study: | 25 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Lia Rita A Bittencourt, MD, PhD | 55 11 21490155 | lia@psicobio.epm.br |
| Contact: Giovana Lúcia A Diaféria, SLP | 55 11 21490155 | gidiaferia@hotmail.com |
| Brazil | |
| Associação Fundo de Incentivo a Psicofarmacologia | Recruiting |
| São Paulo, SP, Brazil, 04024-002 | |
| Contact: Lia Rita A Bittencourt, MD, PhD 55 11 21490155 lia@psicobio.epm.br | |
| Contact: Giovana Lúcia A Diaféria, SLP 55 11 21490155 gidiaferia@hotmail.com | |
| Sub-Investigator: Giovana Lúcia A Diaféria, SLP | |
| Principal Investigator: | Lia Rita A Bittencourt, MD, PhD | Universidade Federal de São Paulo |
More Information
No publications provided
| Responsible Party: | Prof. Dr. Lia Azeredo-Bittencourt, professor, Associacao Fundo de Incentivo a Psicofarmcologia |
| ClinicalTrials.gov Identifier: | NCT01289405 History of Changes |
| Other Study ID Numbers: | CEP 2002/08 |
| Study First Received: | February 1, 2011 |
| Last Updated: | October 25, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
|
obstructive sleep apnea oropharyngeal exercises speech therapy |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013