Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT01289405
First received: February 1, 2011
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea Syndrome
Device: Continuous Positive Airway Pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Associação Fundo de Incentivo à Pesquisa:

Primary Outcome Measures:
  • objective sleep pattern [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography


Secondary Outcome Measures:
  • somnolence [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    score of Epworth Sleepiness Scale

  • Quality of Life [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    score of WHOQOL-BREF and FOSQ questionnaires

  • Cognition [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Evaluations of Psychomotor Vigilance Test


Enrollment: 80
Study Start Date: October 2010
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01289405

Locations
Brazil
Associação Fundo de Incentivo a Psicofarmacologia
São Paulo, SP, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Investigators
Principal Investigator: Lia Rita A Bittencourt, MD, PhD Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, professor, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT01289405     History of Changes
Other Study ID Numbers: CEP 2002/08
Study First Received: February 1, 2011
Last Updated: February 5, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Associação Fundo de Incentivo à Pesquisa:
obstructive sleep apnea
oropharyngeal exercises
speech therapy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014