NCT05346705

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

Status unknown NA Last updated 26 April 2022

What this trial tests

NA trial testing New individualized upper airway muscle functional training in Obstructive Sleep Apnea in 300 participants. Status unknown.

Timeline

1 January 2022

Primary endpoint
1 January 2025

1 May 2025

Quick facts

Lead sponsor	First Hospital of China Medical University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	300
Start date	1 January 2022
Primary completion	1 January 2025
Estimated completion	1 May 2025
Sites	1 location across China

Drugs / interventions tested

• New individualized upper airway muscle functional training

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →
• Muscle Disorder — all drugs for Muscle Disorder →

Sponsor

First Hospital of China Medical University

Who can join

Adults 18 to 75, any sex, with Obstructive Sleep Apnea or Muscle Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.