跳至主要内容
临床试验/NCT00660777
NCT00660777已完成3 期

Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea: A Randomized, Controlled Study

University of Sao Paulo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2004年2月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
30
试验地点
2
主要终点
Apnea-hypopnea index

研究概览

简要总结

Background: Upper airway muscle weakness plays an important role in the genesis of obstructive sleep apnea (OSA). Oropharyngeal exercises are derived from speech therapy consisting of isometric and isotonic exercises directed to tongue, soft palate and lateral pharyngeal wall. We hypothesized that oropharyngeal exercises will attenuate OSA severity.

We will include 30 moderate OSA patients (apnea-hypopnea index (AHI), between 15 and 30 events/hour) that will randomize to 3 months of general measurements and daily nasal lavage (n=15, control) or daily oropharyngeal exercises (~30 min) plus nasal lavage (n=16). Full polysomnography, anthropometric measurements, questionnaires derived from Berlin, Epworth and Pittsburgh evaluating quantitatively (range) snoring frequency (0-4) and intensity (1-3), daytime sleepiness (0-24) and sleep quality (0-21), respectively will be performed at baseline and study end.

详细描述

Patients: Eligible patients aged between 25 e 65 years old with a recent diagnosis of moderate OSA evaluated in the sleep laboratory, Pulmonary Division, Heart Institute (InCor). We will exclude patients with one or more of the follow conditions: body mass index (BMI) >40 kg/m2; facial malformations; regular use of hypnotic medications, hypothyroidism, previous stroke, neuromuscular disease, heart failure, coronary disease, and severe obstructive nasal disease.

Polysomnography: All patients will be evaluated by full polysomnography. The person who analyzed the sleep study will be blind to the group allocation.

Questionnaire: We will employ questionnaires previously validated and used in Brazil: Snoring frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire).

Control Group: Sham therapy will consisted of a weekly supervised section (~30 min) of deep breathing, through the nose, while sitting, followed by a practice of bilateral alternate chewing. The patients will be instructed to perform the same procedure at home once a day (30 min), plus alternate bilateral chewing and nasal lavage with application of 10 ml of saline in each nostril three times a day.

Study Group: The same schedule and set of instructions will be applied to the control group was given to these patients. Oropharyngeal exercises are derived from speech language pathology and include soft palate, tongue and facial muscles exercises as well as stomatognathic function exercises.

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
Single (Participant)

入排标准

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

入选标准

  • Patients aged between 25 and 65 years old with a recent diagnosis of moderate obstructive sleep apnea

排除标准

  • Body mass index (BMI) >40 kg/m2
  • 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

Apnea-hypopnea index

时间窗: 3 months

次要结局

  • Lowest oxygen saturation(3 months)
  • Sleep related questionnaires(3 months)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验