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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346705
• Other study ID #: AF-SOP-07-1.1-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: April 2022
• Source: First Hospital of China Medical University
• Contact: Wenyang Li, PhD
• Phone: 15009882216
• Email: sisy_[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Disorder
• Muscular Diseases
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
China	First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of China Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Cortical motor center excitability of upper airway muscle	Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV)	Baseline and 1 Week
Secondary	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