Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

Associação Fundo de Incentivo à Pesquisa

Status: Completed

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Device: Continuous Positive Airway Pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01289405

CEP 2002/08

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

placebo exercices

Placebo Comparator group

Description:

relaxation exercises and stretching neck, without therapeutic purpose.

Treatment:

Device: Continuous Positive Airway Pressure (CPAP)

phonoaudiologic therapy

Active Comparator group

Description:

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.

Treatment:

Device: Continuous Positive Airway Pressure (CPAP)