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

China Medical University

Status: Enrolling

Conditions: Muscle Disorder; Obstructive Sleep Apnea

Treatments: Behavioral: New individualized upper airway muscle functional training

Study type: Interventional

Funder types: Other

Identifiers

NCT05346705

AF-SOP-07-1.1-01

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 3 patient groups, including a placebo group

Tongue/soft palate muscle control function training group

Experimental group

Description:

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

Treatment:

Behavioral: New individualized upper airway muscle functional training

Soft palate muscle group vocal resistance training group

Experimental group

Description:

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

Treatment:

Behavioral: New individualized upper airway muscle functional training

Simple tongue extension, cheek drumming/voice training group

Placebo Comparator group

Description:

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

Treatment:

Behavioral: New individualized upper airway muscle functional training