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

Primary Purpose

Obstructive Sleep Apnea, Muscle Disorder

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
New individualized upper airway muscle functional training
Sponsored by
First Hospital of China Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • First Hospital of China Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Tongue/soft palate muscle control function training group

Soft palate muscle group vocal resistance training group

Simple tongue extension, cheek drumming/voice training group

Arm 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

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

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

Outcomes

Primary Outcome Measures

Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria
Sleep Parameters Changes : Snoring index
Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria

Secondary Outcome Measures

Upper Airway Muscle Strength (genioglossus)
Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N)
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)
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.
Cortical motor center excitability of upper airway muscle
Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV)
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).

Full Information

First Posted
April 8, 2022
Last Updated
April 21, 2022
Sponsor
First Hospital of China Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05346705
Brief Title
Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
Official Title
Effects of Newly-created Individualized Upper Airway Muscle Functional Training on Patients With OSA
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First Hospital of China Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Muscle Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tongue/soft palate muscle control function training group
Arm Type
Experimental
Arm 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
Arm Title
Soft palate muscle group vocal resistance training group
Arm Type
Experimental
Arm 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
Arm Title
Simple tongue extension, cheek drumming/voice training group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
New individualized upper airway muscle functional training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sleep Parameters Changes : Apnea Hypopnea Index (AHI)
Description
Overnight polysomnography with Alice5 (Philips); AHI measured according to American Association of Sleep Medicine (AASM) criteria
Time Frame
Baseline and 1 Week
Title
Sleep Parameters Changes : Oxygen desaturation index (ODI)
Description
Overnight polysomnography with Alice5 (Philips); ODI measured according to American Association of Sleep Medicine (AASM) criteria
Time Frame
Baseline and 1 Week
Title
Sleep Parameters Changes : Snoring index
Description
Overnight polysomnography with Alice5 (Philips); Snoring index measured according to American Association of Sleep Medicine (AASM) criteria
Time Frame
Baseline and 1 Week
Secondary Outcome Measure Information:
Title
Upper Airway Muscle Strength (genioglossus)
Description
Measurement of Genioglossus Strength Using the New Individualized Upper Airway Muscle Training Machine: Measuring Tongue Extension Strength (N)
Time Frame
Baseline and 1 Week
Title
Upper Airway Muscle Strength (Soft palate muscles)
Description
Measuring Soft Palate Muscle Strength Using the New Personalized Upper Airway Muscle Training Machine: Measuring Soft Palate Muscle Resistant Pressure (kPa)
Time Frame
Baseline and 1 Week
Title
Quality of Life (as measured by Berlin Questionnaire)
Description
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.
Time Frame
Baseline and 1 Week
Title
Cortical motor center excitability of upper airway muscle
Description
Measured byTranscranial Magnetic Stimulation Machine (Nihon Nkohdencorp) : amplitude (mV)
Time Frame
Baseline and 1 Week
Title
Daytime sleepiness (as measured by Epworth Sleepiness Scale)
Description
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).
Time Frame
Baseline and 1 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenyang Li, PhD
Phone
15009882216
Email
sisy_@126.com
Facility Information:
Facility Name
First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenyang Li, PhD
Phone
15009882216
Email
sisy_@126.com
First Name & Middle Initial & Last Name & Degree
Wei Wang, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data can be requested from researchers after the experiment is over and after the paper is published

Learn more about this trial

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

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