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临床试验/NCT05346705
NCT05346705Unknown不适用

Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA

First Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Sleep Parameters Changes : Oxygen desaturation index (ODI)

研究概览

简要总结

Objectives: To observe the effect of newly-created individualized upper airway muscle functional training on the condition and intraday symptoms of OSA patients; to study the effect of this training method on the excitability of the genioglossus muscle cortex; to analyze the factors affecting the efficacy of upper airway training in the treatment of OSA and screening suitable population for upper airway training: Design: A randomized double-blind controlled trial. SAS 9.3 statistical software (SAS Institute, Cary, North Carolina, USA) was used to generate a random number table, and the selected patients were randomly divided into experimental group 1, experimental group 2, and control group according to the ratio of 1:1:1 with 100 cases each.

Unit: Shenyang, China Participants: Consecutive specific OSA patients, who are potential candidates for the treatment of upper airway training (n=300), will be recruited from a sleep center or respirologists, psychiatrists, otolaryngologists and dentists practicing with broad inclusion criteria (age: 20-75 years, AHI:15-50/h; BMI<40 kg/m2).

Interventions: The three groups of subjects completed 7-day functional training and control training of upper airway muscles in different modes, respectively completed polysomnography, neck circumference, Berlin questionnaire and Epworth sleepiness scale before and after training, The genioglossus myoelectric activity was measured after transcranial magnetic stimulation and the excitability of the genioglossus cortex motor center was used to determine the efficacy of different training. After regression analysis, the factors affecting the efficacy of upper airway muscle group training were analyzed to screen the OSA patient population suitable for upper airway muscle group training.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Recent diagnosis of OSA (AHI>15 events/h) announced by a sleep recording
  • •Mean oxygen saturation >90%
  • •Must be able to complete the training

排除标准

  • •Inability to tolerate overnight polysomnography in sleep lab
  • •>50% of observed sleep apneas being central
  • •Other sleep disorders such as insomnia, narcolepsy, chronic sleep deficiency, periodic limb movement disorder or restless legs syndrome

研究组 & 干预措施

Tongue/soft palate muscle control function training group

Experimental

In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor

干预措施: New individualized upper airway muscle functional training (Behavioral)

Soft palate muscle group vocal resistance training group

Experimental

In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor

干预措施: New individualized upper airway muscle functional training (Behavioral)

Simple tongue extension, cheek drumming/voice training group

Placebo Comparator

In the sleep center, patients undergo a week of upper airway muscle training for 2 hours a day under the guidance of a doctor

干预措施: New individualized upper airway muscle functional training (Behavioral)

结局指标

主要结局

Sleep Parameters Changes : Oxygen desaturation index (ODI)

时间窗: Baseline and 1 Week

Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria

Sleep Parameters Changes : Apnea Hypopnea Index (AHI)

时间窗: Baseline and 1 Week

Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria

Sleep Parameters Changes : Snoring index

时间窗: Baseline and 1 Week

Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria

次要结局

  • Upper Airway Muscle Strength (genioglossus)(Baseline and 1 Week)
  • Cortical motor center excitability of upper airway muscle(Baseline and 1 Week)
  • Upper Airway Muscle Strength (Soft palate muscles)(Baseline and 1 Week)
  • Quality of Life (as measured by Berlin Questionnaire)(Baseline and 1 Week)
  • Daytime sleepiness (as measured by Epworth Sleepiness Scale)(Baseline and 1 Week)

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wenyang Li

Associate Professor

First Hospital of China Medical University

研究点 (1)

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