Obstructive Sleep Apnea of AdultNCT05739617
Comprehensive Respiratory Training Exercise Program in Obstructive Sleep Apnea
A study testing Comprehensive Respiratory Training Exercise Program and Sleep hygiene education in people with Obstructive Sleep Apnea of Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Comprehensive Respiratory Training Exercise Program and Sleep hygiene education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2023to 16 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Ching-Hsia Hung, PhD, 06-2353535 ext. 5939, chhung@mail.ncku.edu.tw
About this study
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
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Comprehensive Respiratory Training Exercise Program, Sleep hygiene education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Respiratory Training Exercise ProgramOther
This comprehensive respiratory training exercise program consists of four main components, including oropharyngeal muscle training, respiratory muscle training, aerobic exercise, and sleep hygiene education.
Sleep hygiene educationOther
Sleep hygiene education
| Study group | Role | What they receive |
|---|---|---|
| Sleep Hygiene Education | Sham comparator | Participants will received once per month of sleep hygiene education for three months. Receives: Other: Sleep hygiene education |
| Comprehensive Respiratory Training Exercise Program | Experimental | Participants will received Comprehensive Respiratory Training Exercise Program twice per weeks for three months. Receives: Other: Comprehensive Respiratory Training Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
Secondary outcomes (4)
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.
Measured: Baseline to 3 months (post-training)
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.
Measured: Baseline to 3 months (post-training)
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%.
Measured: Baseline to 3 months (post-training)
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%.
Measured: Baseline to 3 months (post-training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Mar 2023
- Primary completion20 May 2026 (estimated)
- Study completion16 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ching-Hsia Hung, PhD, Principal investigator, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739617
- Sponsor's protocol ID
- A-BR-111-079
- Status last verified
- May 2025
- First submitted
- 8 Feb 2023
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05739617
- Acronym / sponsor ID
- A-BR-111-079
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 20 May 2026 (estimated)
- Study completion
- 16 Jul 2026 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Hygiene Education | Sham comparator | Other: Sleep hygiene educationParticipants will received once per month of sleep hygiene education for three months. |
| Comprehensive Respiratory Training Exercise Program | Experimental | Other: Comprehensive Respiratory Training Exercise ProgramParticipants will received Comprehensive Respiratory Training Exercise Program twice per weeks for three months. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Newly diagnosed with OSA (AHI≥ 5 events per hour)
- Age between 20 to 65 years old
- BMI of 18-30 kg.m-2
- Central or mixed types of sleep apnea
- Neuromuscular disease
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Respiratory Training Exercise ProgramThis comprehensive respiratory training exercise program consists of four main components, including oropharyngeal muscle training, respiratory muscle training, aerobic exercise, and sleep hygiene education. | Other | Comprehensive Respiratory Training Exercise Program |
| Sleep hygiene educationSleep hygiene education | Other | Sleep Hygiene Education |
Primary outcome
Change in Apnea-Hypopnea Index (AHI)
Time frame: Baseline to 3 months (post-training)
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)
Time frame: Baseline to 3 months (post-training)
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)
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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)
Time frame: Baseline to 3 months (post-training)
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
Time frame: Baseline to 3 months (post-training)
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.
4 secondary outcomes
Change in Maximal Inspiratory Pressure (PImax)
Time frame: Baseline to 3 months (post-training)
Change in Maximal Expiratory Pressure (PEmax)
Time frame: Baseline to 3 months (post-training)
Change in forced vital capacity (FVC) % predicted
Time frame: Baseline to 3 months (post-training)
Change in Forced Expiratory Volume in one second (FEV1)/ forced vital capacity(FVC) %
Time frame: Baseline to 3 months (post-training)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ching-Hsia Hung, PhD principal investigator
National Cheng Kung University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Respiratory Training Exercise Program and Sleep hygiene education in people with Obstructive Sleep Apnea of Adult, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun-Hui Ong, MS (+886-9-37839992, junhui.ong611@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Apnea-Hypopnea Index (AHI) (time frame: Baseline to 3 months (post-training)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.