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

NCT05346705 | Unknown

• 1 other identifier: AF-SOP-07-1.1-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Upper Airway Muscle Strength (genioglossus)

  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

• Cortical motor center excitability of upper airway muscle

  Baseline and 1 Week

• Daytime sleepiness (as measured by Epworth Sleepiness Scale)

  Baseline and 1 Week

Study Arms (3)

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

Behavioral: New individualized upper airway muscle functional training

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

Behavioral: New individualized upper airway muscle functional training

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

Behavioral: New individualized upper airway muscle functional training

Interventions

New individualized upper airway muscle functional training 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; Soft palate muscle group vocal resistance training group; Tongue/soft palate muscle control function training group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Hospital of China Medical University: lead

Study Sites (1)

First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Muscular Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases

Central Study Contacts

Wenyang Li, PhD

CONTACT

15009882216; sisy_@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 26, 2022
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)