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临床试验/NCT01289405
NCT01289405已完成不适用

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

Associação Fundo de Incentivo à Pesquisa2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2010年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
objective sleep pattern

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

objective sleep pattern

时间窗: 90 days

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

次要结局

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

研究者

发起方
Associação Fundo de Incentivo à Pesquisa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Lia Azeredo-Bittencourt

professor

Associação Fundo de Incentivo à Pesquisa

研究点 (2)

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