Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Continuous Positive Airway Pressure (CPAP)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04024-002
      • Associacao Fundo de Incentivo a Psicofarmacologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
objective sleep pattern	sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
somnolence	score of Epworth Sleepiness Scale	90 days
Quality of Life	score of WHOQOL-BREF and FOSQ questionnaires	90 days
Cognition	Evaluations of Psychomotor Vigilance Test	90 days

Collaborators and Investigators

• Sponsor: Associação Fundo de Incentivo à Pesquisa
• Investigators: Principal Investigator: Lia Rita A Bittencourt, MD, PhD, Universidade Federal de Sao Paulo

Publications and helpful links

General Publications

• Diaferia G, Santos-Silva R, Truksinas E, Haddad FLM, Santos R, Bommarito S, Gregorio LC, Tufik S, Bittencourt L. Myofunctional therapy improves adherence to continuous positive airway pressure treatment. Sleep Breath. 2017 May;21(2):387-395. doi: 10.1007/s11325-016-1429-6. Epub 2016 Dec 2.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 2, 2011
• First Posted (Estimate): February 3, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: February 5, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; speech therapy; oropharyngeal exercises
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome; Apnea
• Other Study ID Numbers: CEP 2002/08