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OpenTrials
Completed

NCT Number: NCT01289405

Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Positive Airway Pressure (CPAP)

Device

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

Primary outcomes

  1. objective sleep pattern

    Time frame: 90 days

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

Secondary outcomes

  1. somnolence

    Time frame: 90 days

    score of Epworth Sleepiness Scale

  2. Quality of Life

    Time frame: 90 days

    score of WHOQOL-BREF and FOSQ questionnaires

  3. Cognition

    Time frame: 90 days

    Evaluations of Psychomotor Vigilance Test

Sponsors and collaborators

Lead sponsor

Associação Fundo de Incentivo à Pesquisa

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
First posted
Feb 3, 2011
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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