Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome
NCT number | NCT01289405 |
Other study ID # | CEP 2002/08 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | February 1, 2011 |
Last updated | February 5, 2014 |
Start date | October 2010 |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 25 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Brazil | Associação Fundo de Incentivo a Psicofarmacologia | São Paulo | SP |
Lead Sponsor | Collaborator |
---|---|
Associação Fundo de Incentivo à Pesquisa |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | objective sleep pattern | sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography | 90 days | Yes |
Secondary | somnolence | score of Epworth Sleepiness Scale | 90 days | No |
Secondary | Quality of Life | score of WHOQOL-BREF and FOSQ questionnaires | 90 days | No |
Secondary | Cognition | Evaluations of Psychomotor Vigilance Test | 90 days | No |
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