Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

NCT01289405 | Completed DMC

• 1 other identifier: CEP 2002/08
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

obstructive sleep apnea; oropharyngeal exercises; speech therapy

Outcome Measures

Primary Outcomes (1)

• objective sleep pattern

  sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography

  90 days

Secondary Outcomes (3)

• somnolence

  90 days

• Quality of Life

  90 days

• Cognition

  90 days

Study Arms (2)

placebo exercices

PLACEBO COMPARATOR

relaxation exercises and stretching neck, without therapeutic purpose.

Device: Continuous Positive Airway Pressure (CPAP)

phonoaudiologic therapy

ACTIVE COMPARATOR

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)

Interventions

Continuous Positive Airway Pressure (CPAP) DEVICE

mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea

phonoaudiologic therapy; placebo exercices

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a recent diagnosis of OSAS
• Body mass index (BMI) \< 35 kg/m2

You may not qualify if:

• Facial malformations
• Regular use of hypnotic medications
• Hypothyroidism
• Previous stroke
• Neuromuscular disease
• Heart failure
• Coronary disease
• Severe obstructive nasal disease

Sponsors & Collaborators

• Associação Fundo de Incentivo à Pesquisa: lead

Study Sites (1)

Associação Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (1)

• 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.

  PMID: 27913971 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Communication Disorders

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Lia Rita A Bittencourt, MD, PhD

  Universidade Federal de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 1, 2011
• First Posted: February 3, 2011
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Last Updated: February 6, 2014

Record last verified: 2014-02

Locations

BR (1)