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临床试验/NCT05320952
NCT05320952已完成不适用

Effect of Upper Respiratory Muscle Strength Exercise on Sleep Apnea Using WellO2 Respiratory Exercise Device

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Apnea-hypopnea index, AHI

研究概览

简要总结

Background:

Obstructive sleep apnea is one of our common diseases and up to 80% of patients are estimated to be undiagnosed. Its main risk factors are overweight, age, male gender, menopause, small jaw, sedative medications / drugs and alcohol. The most important treatment for sleep apnea is continuous positive airway pressure (CPAP). However, not all patients adapt or benefit from device therapy, and up to about 60% stop using the device. Underlying sleep apnea are mechanisms other than anatomical factors such as respiratory wake sensitivity, loop gain control function, and upper respiratory tract muscle activation response and efficiency. Depending on which of these mechanisms dominates as the cause of sleep apnea, the patient's phenotype may vary and CPAP device therapy may not be the correct form of treatment for all patients. Therefore, new targeted therapies should be developed.

The WellO2 breathing training device performs back-pressure steam breathing training during the inhalation and exhalation phases. WellO2 effectively exercises the power of the inspiratory muscles, increases the inspiratory muscles, reduces the feeling of dyspnea due to exertion, increases the economy of respiration and delays inhalation muscles. It is a drug-free treatment and easy to use. The use of the WellO2 ventilator has not been previously studied in sleep apnea patients.

详细描述

Research objectives:

  1. Will AHI change after 3 months of use of WellO2 (PSG in the beginning and after 3 months)
  2. Will the participants get help with fatigue symptoms or quality of life (questionnaires)
  3. Is there a response to WellO2 treatment in AHI and symptoms of sleep apnea still after 3 months of WellO2 treatment washout (PSG 3 months after treatment discontinuation)
  4. Are the participants able to use the device (questionnaires)

Research design:

A clinical follow-up study in lung clinic sleep apnea patients who are not receiving any other form of sleep apnea treatment. The estimate for the recruitment phase is 6-12 months. The duration of the study is 6 months, of which the active phase with the WellO2 breathing apparatus is 3 months and the washout phase is 3 months after the end of treatment.

Material:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-60 years
  • Male:Famel 1:1
  • AHI 10-29 / h
  • working patients

排除标准

  • Previous surgical treatment for sleep apnea, current CPAP or mandibular device therapy
  • significant history of nasal, oral and pharyngeal disorders
  • BMI> 40 kg / m2
  • other severe pulmonary diseases (eg COPD, asthma, pulmonary fibrosis) severe heart failure (NYHA 3-4), previous brain insult, neuromuscular disease or pregnancy, and work disability.

结局指标

主要结局

Apnea-hypopnea index, AHI

时间窗: 3 months

Change in AHI measured from polysomnogaphy in the beginning and after 3 month's of WellO2 treatment?

次要结局

  • WellO2 device usability(3 months)
  • Sleep apnea symptoms(3 months)
  • Longterm benefits in AHI and symptoms of sleep apnea(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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