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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2014
Source Associação Fundo de Incentivo à Pesquisa
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Intervention

Device:
Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea

Locations

Country Name City State
Brazil Associação Fundo de Incentivo a Psicofarmacologia São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

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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