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Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Comprehensive Respiratory Training Exercise Program
Sleep hygiene education
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed with OSA (AHI≥ 5 events per hour) Age between 20 to 65 years old BMI of 18-30 kg.m-2 Exclusion Criteria: Diagnosed with any of the following diseases below: Central or mixed types of sleep apnea Neuromuscular disease Severe cardiovascular disease Active psychiatric disease Head or neck disease or cancer Structural abnormalities over the upper respiratory airway Performed any operation or treatment over the neck before Pregnancy

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sleep Hygiene Education

Comprehensive Respiratory Training Exercise Program

Arm Description

Participants will received once per month of sleep hygiene education for three months.

Participants will received Comprehensive Respiratory Training Exercise Program twice per weeks for three months.

Outcomes

Primary Outcome Measures

Change in Apnea-Hypopnea Index (AHI)
The apnea-hypopnea index will be obtained from the overnight Polysomnography (PSG) study. PSG will be performed in the sleep center of National Cheng Kung University Hospital. Less than 5 events/hour indicates normal; AHI between 5-14 events/hour indicates mild Obstructive Sleep Apnea(OSA); AHI between 15-30 events/hour indicates moderate OSA; and AHI more than 30 events/hour indicates severe OSA.
Change in Oxygen Desaturation Index (ODI)
The average number of desaturation episodes per hour (oxygen desaturation index) will be obtained from the overnight Polysomnography (PSG) study. A decrease in the mean oxygen saturation of ≥4% that lasts for at least 10 seconds indicates an episode of desaturation.
Change in Maximum Oxygen Consumption (Vo2max)
Maximum oxygen consumption (Vo2max) will be measured using Cardiopulmonary Exercise Testing (CPET) which will be performed on a static bicycle. The average value of Vo2max in adults is approximately 27-48 mL/kg/min. A greater Vo2max value indicates a better physical fitness level.
Change in Tongue Muscle Thickness
Sonography will be performed over the participant's neck region to assess the changes in tongue muscle thickness during normal breathing, Müller's maneuver, functional tasks, and natural sleep. The data on tongue thickness will be presented in millimeters. A greater value indicates a thicker in tongue.
Change in Tongue Muscle Stiffness
Ultrasound shear-wave elastography will be performed to assess the changes in tongue-based stiffness. The data will be presented in kPa, with a greater value indicating an increase in tongue stiffness. The minimum value is 0 kPa and the maximum value is 220 kPa.
Change in Tongue Muscle Strength
The tongue muscle strength will be measured using an Iowa Oral Performance Instrument (IOPI) device, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). The minimum score is 0 and a higher score indicates stronger in tongue muscle strength.
Change in Tongue Muscle Endurance
The tongue muscle endurance will be measured using an Iowa Oral Performance Instrument (IOPI) device, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). The data will be presented in seconds. The longer the duration of holding (more than 10 seconds), the greater in the tongue muscle endurance.
Change in Jaw strength
Jaw strength will be measured using a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA). The data will be presented in kilogram-weight. The minimum score is 0 and a higher score indicates stronger in jaw strength.
Change in Pharyngeal Airway Volume
Computer Tomography (CT) will be performed. The pharyngeal airway volume will be calculated from the hard palate to the epiglottis and the data will be presented in cm3. The minimum score is 0 and a higher score indicates greater in pharyngeal airway volume.
Change in Cross Section Area on the Tip of Epiglottis
Computer Tomography (CT) will be performed. Cross section area on the tip of the epiglottis was measured and the data will be presented in cm2. The minimum score is 0 and a higher score indicates greater in the cross-sectional area of the region.
Change in Anterior to Posterior Distance on the Tip of the Epiglottis
The distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the anterior to posterior in this area.
Change in Lateral Distance on the Tip of Epiglottis
The distance between the lateral distance on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the lateral wall.
Change in daytime sleepiness
Epworth Sleepiness Score(ESS) will be used to measure the daytime sleepiness of OSA patients. The total score of ESS range from 0-24. A score greater than 10 indicates greater daytime sleepiness.
Change in Drug-induced Sleep Endoscopy (DISE)
The level of obstruction, the degree of obstruction, and the configuration of the obstructive will be identified through the drug-induced sleep endoscopy. The degree of obstruction ranged from 0 to 2. 0: no obstruction; 1: partial obstruction; 2: complete obstruction.
Change in sleep quality
Sleep quality will be measured using Pittsburgh Sleep Quality Index (PSQI).The total score ranges from 0 to 21 with a higher total score equal to or more than 5 indicating worse sleep quality.

Secondary Outcome Measures

Change in Maximal Inspiratory Pressure (PImax)
For respiratory muscle strength, maximal inspiratory pressure (PImax) will be measured using Respiratory Pressure Meter. Data will be presented in cmH2O. The minimal score will be 0, and a higher value indicates stronger in the inspiratory muscle.
Change in Maximal Expiratory Pressure (PEmax)
For respiratory muscle strength, maximal expiratory pressure (PEmax) will be measured using Respiratory Pressure Meter. Data will be presented in cmH2O. The minimal score will be 0, and a higher value indicates stronger in the expiratory muscle.
Change in forced vital capacity (FVC) % predicted
The respiratory muscle function on the forced vital capacity (FVC) % predicted will be collected using spirometry. The normal value is between 80% to 120%; mild abnormality: is 70-79%; moderate abnormality: is 60-69%; severe abnormality: is less than 60%.
Change in Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) %
The respiratory muscle function on the Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) will be collected using spirometry. The normal value for the FEV1/FVC % is equal to or greater than 70%; mild abnormality: 60-69%; moderate abnormality: 50-59%; severe abnormality: less than 50%.

Full Information

First Posted
February 8, 2023
Last Updated
October 18, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05739617
Brief Title
Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea
Official Title
Combining Sonography to Explore the Therapeutic Effect and Mechanism of a Comprehensive Respiratory Training Exercise Program on Cardiorespiratory Endurance and Airway Muscle Function in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

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

5. Study Description

Brief Summary
Obstructive sleep apnea (OSA) is a multi-factorial sleep disorder. Complete collapse or partial collapse in the airway increases the risk of developing cardiovascular and kidney-related disease in OSA patients. Resulting in an increase in medical expenses and workload for the healthcare worker. Multilevel of upper airway muscles especially the genioglossus muscle showed to contribute to airway obstruction as it fatigues easily. The endurance level of OSA patients was shown to be significantly lower. Therefore, the goal of this experimental study is to assess the feasibility and effectiveness of a comprehensive respiratory training exercise program on cardiorespiratory endurance, airway muscle function, and sleep parameters in patients with obstructive sleep apnea (OSA). Aside from exploring the therapeutic effect, the results of the study will be used to explore the mechanism of the treatment in relation to the changes in the OSA severity.
Detailed Description
Newly diagnosed OSA subjects, aged 20-65 years old, and with body mass index between 18-30 kg.m-2 will be recruited. The participants will be randomly divided into the control group (sleep hygiene education) and the intervention group (comprehensive respiratory training exercise program). Participants from the intervention group will undergo 3 months of a comprehensive respiratory training exercise program while the control group will be provided sleep hygiene education. Polysomnography (PSG), cardiopulmonary exercise testing, sonography (during the awake stage, functional tasks, Müller's maneuver, and natural sleep), tongue strength and tongue endurance assessment, jaw strength measurement, Computed Tomography (CT), Drug-Induced Sleep Endoscopy (DISE), respiratory muscle strength, pulmonary function test, and sleep quality questionnaires will be collected before and after 3 months of intervention. Expected contribution to clinical medicine The feasibility of this comprehensive respiratory training exercise program in improving cardiorespiratory endurance, leading to an increase in the survival rate and reduced risk of cardiovascular disease of OSA patients. Based on the ultrasound's findings in the awake stage (normal breathing, functional tasks, and Müller's maneuver) and overnight sleep, allow a better understanding of the effects of these exercises on the changes of tongue and oropharyngeal structures during the static and dynamic stages. The practicability of the ultrasound assessment in the clinical setting on OSA patients is to identify the changes in the tongue and oropharyngeal structures. Based on ultrasound image capture, it provides individualized and precise training by modifying the training and providing feedback to OSA patients during their exercise training.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Hygiene Education
Arm Type
Sham Comparator
Arm Description
Participants will received once per month of sleep hygiene education for three months.
Arm Title
Comprehensive Respiratory Training Exercise Program
Arm Type
Experimental
Arm Description
Participants will received Comprehensive Respiratory Training Exercise Program twice per weeks for three months.
Intervention Type
Other
Intervention Name(s)
Comprehensive Respiratory Training Exercise Program
Intervention Description
This comprehensive respiratory training exercise program consists of four main components, including oropharyngeal muscle training, respiratory muscle training, aerobic exercise, and sleep hygiene education.
Intervention Type
Other
Intervention Name(s)
Sleep hygiene education
Intervention Description
Sleep hygiene education
Primary Outcome Measure Information:
Title
Change in Apnea-Hypopnea Index (AHI)
Description
The apnea-hypopnea index will be obtained from the overnight Polysomnography (PSG) study. PSG will be performed in the sleep center of National Cheng Kung University Hospital. Less than 5 events/hour indicates normal; AHI between 5-14 events/hour indicates mild Obstructive Sleep Apnea(OSA); AHI between 15-30 events/hour indicates moderate OSA; and AHI more than 30 events/hour indicates severe OSA.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Oxygen Desaturation Index (ODI)
Description
The average number of desaturation episodes per hour (oxygen desaturation index) will be obtained from the overnight Polysomnography (PSG) study. A decrease in the mean oxygen saturation of ≥4% that lasts for at least 10 seconds indicates an episode of desaturation.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Maximum Oxygen Consumption (Vo2max)
Description
Maximum oxygen consumption (Vo2max) will be measured using Cardiopulmonary Exercise Testing (CPET) which will be performed on a static bicycle. The average value of Vo2max in adults is approximately 27-48 mL/kg/min. A greater Vo2max value indicates a better physical fitness level.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Tongue Muscle Thickness
Description
Sonography will be performed over the participant's neck region to assess the changes in tongue muscle thickness during normal breathing, Müller's maneuver, functional tasks, and natural sleep. The data on tongue thickness will be presented in millimeters. A greater value indicates a thicker in tongue.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Tongue Muscle Stiffness
Description
Ultrasound shear-wave elastography will be performed to assess the changes in tongue-based stiffness. The data will be presented in kPa, with a greater value indicating an increase in tongue stiffness. The minimum value is 0 kPa and the maximum value is 220 kPa.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Tongue Muscle Strength
Description
The tongue muscle strength will be measured using an Iowa Oral Performance Instrument (IOPI) device, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). The minimum score is 0 and a higher score indicates stronger in tongue muscle strength.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Tongue Muscle Endurance
Description
The tongue muscle endurance will be measured using an Iowa Oral Performance Instrument (IOPI) device, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA). The data will be presented in seconds. The longer the duration of holding (more than 10 seconds), the greater in the tongue muscle endurance.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Jaw strength
Description
Jaw strength will be measured using a 'handheld' dynamometer (MicroFET○R2, Hoggan Scientific, USA). The data will be presented in kilogram-weight. The minimum score is 0 and a higher score indicates stronger in jaw strength.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Pharyngeal Airway Volume
Description
Computer Tomography (CT) will be performed. The pharyngeal airway volume will be calculated from the hard palate to the epiglottis and the data will be presented in cm3. The minimum score is 0 and a higher score indicates greater in pharyngeal airway volume.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Cross Section Area on the Tip of Epiglottis
Description
Computer Tomography (CT) will be performed. Cross section area on the tip of the epiglottis was measured and the data will be presented in cm2. The minimum score is 0 and a higher score indicates greater in the cross-sectional area of the region.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Anterior to Posterior Distance on the Tip of the Epiglottis
Description
The distance between the anterior and posterior pharyngeal wall on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the anterior to posterior in this area.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Lateral Distance on the Tip of Epiglottis
Description
The distance between the lateral distance on the tip of the epiglottis will be measured and presented in cm. The minimal value will be 0 and the greater value indicates a greater distance between the lateral wall.
Time Frame
Baseline to 3 months (post-training)
Title
Change in daytime sleepiness
Description
Epworth Sleepiness Score(ESS) will be used to measure the daytime sleepiness of OSA patients. The total score of ESS range from 0-24. A score greater than 10 indicates greater daytime sleepiness.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Drug-induced Sleep Endoscopy (DISE)
Description
The level of obstruction, the degree of obstruction, and the configuration of the obstructive will be identified through the drug-induced sleep endoscopy. The degree of obstruction ranged from 0 to 2. 0: no obstruction; 1: partial obstruction; 2: complete obstruction.
Time Frame
Baseline to 3 months (post-training)
Title
Change in sleep quality
Description
Sleep quality will be measured using Pittsburgh Sleep Quality Index (PSQI).The total score ranges from 0 to 21 with a higher total score equal to or more than 5 indicating worse sleep quality.
Time Frame
Baseline to 3 months (post-training)
Secondary Outcome Measure Information:
Title
Change in Maximal Inspiratory Pressure (PImax)
Description
For respiratory muscle strength, maximal inspiratory pressure (PImax) will be measured using Respiratory Pressure Meter. Data will be presented in cmH2O. The minimal score will be 0, and a higher value indicates stronger in the inspiratory muscle.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Maximal Expiratory Pressure (PEmax)
Description
For respiratory muscle strength, maximal expiratory pressure (PEmax) will be measured using Respiratory Pressure Meter. Data will be presented in cmH2O. The minimal score will be 0, and a higher value indicates stronger in the expiratory muscle.
Time Frame
Baseline to 3 months (post-training)
Title
Change in forced vital capacity (FVC) % predicted
Description
The respiratory muscle function on the forced vital capacity (FVC) % predicted will be collected using spirometry. The normal value is between 80% to 120%; mild abnormality: is 70-79%; moderate abnormality: is 60-69%; severe abnormality: is less than 60%.
Time Frame
Baseline to 3 months (post-training)
Title
Change in Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) %
Description
The respiratory muscle function on the Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) will be collected using spirometry. The normal value for the FEV1/FVC % is equal to or greater than 70%; mild abnormality: 60-69%; moderate abnormality: 50-59%; severe abnormality: less than 50%.
Time Frame
Baseline to 3 months (post-training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Newly diagnosed with OSA (AHI≥ 5 events per hour) Age between 20 to 65 years old BMI of 18-30 kg.m-2 Exclusion Criteria: Diagnosed with any of the following diseases below: Central or mixed types of sleep apnea Neuromuscular disease Severe cardiovascular disease Active psychiatric disease Head or neck disease or cancer Structural abnormalities over the upper respiratory airway Performed any operation or treatment over the neck before Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun-Hui Ong, MS
Phone
+886-9-37839992
Email
junhui.ong611@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ching-Hsia Hung, PhD
Phone
+886-6-2353535
Ext
5939
Email
chhung@mail.ncku.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching-Hsia Hung, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Hsia Hung, PhD
Phone
06-2353535
Ext
5939
Email
chhung@mail.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea

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