Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289405
• Other study ID #: CEP 2002/08
• 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. 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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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