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Clinical Trials/NCT01289405
NCT01289405
Completed
Not Applicable

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

Associação Fundo de Incentivo à Pesquisa1 site in 1 country80 target enrollmentOctober 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea Syndrome
Sponsor
Associação Fundo de Incentivo à Pesquisa
Enrollment
80
Locations
1
Primary Endpoint
objective sleep pattern
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2010
End Date
December 2011
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Associação Fundo de Incentivo à Pesquisa
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Lia Azeredo-Bittencourt

professor

Associação Fundo de Incentivo à Pesquisa

Eligibility 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

Outcomes

Primary Outcomes

objective sleep pattern

Time Frame: 90 days

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

Secondary Outcomes

  • somnolence(90 days)
  • Quality of Life(90 days)
  • Cognition(90 days)

Study Sites (1)

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