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

February 1, 2011
February 5, 2014
October 2010
December 2011   (final data collection date for primary outcome measure)
objective sleep pattern [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography
Same as current
Complete list of historical versions of study NCT01289405 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome
Device: Continuous Positive Airway Pressure (CPAP)
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
  • Placebo Comparator: placebo exercices
    relaxation exercises and stretching neck, without therapeutic purpose.
    Intervention: Device: Continuous Positive Airway Pressure (CPAP)
  • 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.
    Intervention: Device: Continuous Positive Airway Pressure (CPAP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
Not Provided
December 2011   (final data collection date for primary outcome measure)

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
Male
25 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01289405
CEP 2002/08
Yes
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
Associação Fundo de Incentivo à Pesquisa
Not Provided
Principal Investigator: Lia Rita A Bittencourt, MD, PhD Universidade Federal de São Paulo
Associação Fundo de Incentivo à Pesquisa
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP