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

NCT ID: NCT05346705

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2025-05-01

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Muscle Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tongue/soft palate muscle control function training group

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

Group Type: EXPERIMENTAL

New individualized upper airway muscle functional training

Intervention Type: BEHAVIORAL

The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.

Soft palate muscle group vocal resistance training group

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

Group Type: EXPERIMENTAL

New individualized upper airway muscle functional training

Intervention Type: BEHAVIORAL

The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.

Simple tongue extension, cheek drumming/voice training group

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

Group Type: PLACEBO_COMPARATOR

New individualized upper airway muscle functional training

Intervention Type: BEHAVIORAL

The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.

Interventions

New individualized upper airway muscle functional training

The two groups of experimental groups were respectively performed tongue/soft palate muscle group control function training and soft palate muscle group vocal resistance training for 7 days.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Hospital of China Medical University

OTHER

Sponsor Role: lead

Responsible Party

Wenyang Li

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenyang Li, PhD

Role: CONTACT

sisy_@126.com

15009882216

Facility Contacts

Wenyang Li, PhD

Role: primary

sisy_@126.com

15009882216

Other Identifiers

AF-SOP-07-1.1-01

Identifier Type: -

Identifier Source: org_study_id