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临床试验/NCT01936038
NCT01936038Unknown1 期

Effectiveness of Upper Airway Toning as Adjuvant Treatment in the Former Period of Adaptation of the Continuous Positive Airway Pressure

Fisiolistic2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2013年6月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
110
试验地点
2
主要终点
CPAP compliance

研究概览

简要总结

The obstructive sleep apnoea/hypopnoea syndrome (OSAHS) is a breathing disorder which happens at night and consists of the interruption of airflow for more than five seconds. His current treatment by continuous positive pressure nocturnal machine (CPAP) is not curative and therefore the level of compliance is key to patient improvement. Many patients don´t tolerate CPAP by the numerous side effects involved. The Upper Airway Toning is a compendium of non-invasive techniques that aim to assist tolerance and compliance with the CPAP. These techniques are: oropharyngeal exercises executed actively by the patient for the muscle toning of the upper airways, electrostimulation of the muscles in the floor of the mouth, correction of the tongue position, nasal and bronchial fogging, execution of respiratory gymnastics, therapy myofascial in the oropharyngeal muscles, manual therapy in the cervical column,and massage in the diaphragm. All the techniques together seek for a greater or lesser impact on the upper airways hypotony, the hypotony of the tongue and the soft palate, the jaw retrognathism, the mouth breathing, the vertebrobasilar syndrome, the gastroesophageal reflux, the excessive accumulation of secretions in the upper and lower airways, the obstructive and restrictive respiratory problems, the sleeping posture, the hypertonia of the diaphragm due to the excess effort in trying to overcome the respiratory obstruction. All these disfunctions will make easier for the patient to show side effects in the use of CPAP. There will be a double-blind randomized controlled study with 110 individuals. One group will follow the conventional medical treatment with CPAP and the other group medical treatment plus Upper Airway Toning. After six months, the mean improvement between the two groups will be compared.

详细描述

OBJECTIVES

Main objective: To increase the percentage of Nasal Continuous Positive Airway Pressure (nCPAP) compliance.

Secondary objectives:

  • To increase the CPAP's tolerance.
  • To decrease the CPAP's pressure.
  • To decrease the daytime sleepiness.
  • To increase the quality of life related to sleep.
  • To assess the level of subjective utility of CPAP by the patient.

METHODOLOGY

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with OSA using CPAP

排除标准

  • Neurological Patients

结局指标

主要结局

CPAP compliance

时间窗: 3 months

nominal variable

次要结局

  • Sleep Apnea Quality of Life Index (SAQLI) Test(3 months)

研究者

发起方
Fisiolistic
申办方类型
Other
责任方
Sponsor

研究点 (2)

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