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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Muscle Disorder
• Intervention / Treatment: Behavioral: New individualized upper airway muscle functional training

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wenyang Li, PhD; Phone Number: 15009882216; Email: sisy_@126.com

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Recruiting
      • First Hospital of China Medical University
      • Contact: Wenyang Li, PhD; Phone Number: 15009882216; Email: sisy_@126.com
      • Principal Investigator: Wei Wang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.
Experimental: 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	Behavioral: 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.
Placebo Comparator: 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	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)	Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria	Baseline and 1 Week
Sleep Parameters Changes : Oxygen desaturation index (ODI)	Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria	Baseline and 1 Week
Sleep Parameters Changes : Snoring index	Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria	Baseline and 1 Week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Airway Muscle Strength (genioglossus)	Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N)	Baseline and 1 Week
Upper Airway Muscle Strength (Soft palate muscles)	Measuring Soft Palate Muscle Strength Using the New Personalized Upper Airway Muscle Training Machine: Measuring Soft Palate Muscle Resistant Pressure (kPa)	Baseline and 1 Week
Quality of Life (as measured by Berlin Questionnaire)	The Berlin scale was used to assess the degree of risk of obstructive sleep apnea-hypopnea syndrome. The questionnaire consisted of 10 questions divided into 3 categories: snoring and apnea (5 questions); excessive daytime sleepiness or fatigue (3 questions); BMI>30 and history of hypertension. 2 or more positive results indicate a high risk of obstructive sleep apnea-hypopnea syndrome, which should be checked by the subjects, and then scored by the medical staff.	Baseline and 1 Week
Cortical motor center excitability of upper airway muscle	Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV)	Baseline and 1 Week
Daytime sleepiness (as measured by Epworth Sleepiness Scale)	Scores on Epworth Sleepiness Scale range from range from 0 to 24, with higher scores indicating higher average sleep propensity in daily life (daytime sleepiness).	Baseline and 1 Week

Collaborators and Investigators

• Sponsor: First Hospital of China Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Musculoskeletal Diseases; Neuromuscular Diseases; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Muscular Diseases
• Other Study ID Numbers: AF-SOP-07-1.1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data can be requested from researchers after the experiment is over and after the paper is published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No