Obstructive Sleep Apnea of AdultNCT06512779
Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
A study testing Surgical Intervention, Oropharyngeal Training (face-to-face) and Oropharyngeal Training (telerehabilitation) 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 syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting approximately 14% of men and 5% of women aged 30-70 years. However, precise clinical prediction tools for selecting optimal treatment strategies are lacking. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- Surgical Intervention, Oropharyngeal Training (face-to-face) and Oropharyngeal Training (telerehabilitation)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Jul 2024to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OSA patients
- Aged over 20 years
Who cannot join
- BMI≧ 32
- Central or mixed types of sleep apnea
- A history of malignancy or infection of the head and neck region and laryngeal trauma
- Craniofacial malformation
- Stroke
- Neuromuscular disease
Show all 11Show fewer
- Severe cardiovascular disease
- Active psychiatric disease
- Structural abnormalities over the upper respiratory airway
- Performed any operation or treatment over the neck before
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 701
Ching-Hsia Hung, Ph.D, 06-2353535 ext. 5939, chhung@mail.ncku.edu.tw
About this study
Obstructive sleep apnea syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting approximately 14% of men and 5% of women aged 30-70 years.
However, precise clinical prediction tools for selecting optimal treatment strategies are lacking. This study aims to develop an automated treatment clustering system using artificial intelligence to classify patients based on etiology into (i) anatomical factors, (ii) reduced muscle responsiveness, and (iii) other non-anatomical factors. This system will analyze physiological sleep assessments, such as electromyography (EMG) and pneumotachographs, from a retrospective polysomnography (PSG) database. Cross-validation will be conducted on new OSA patients undergoing various management strategies, including surgical intervention, CPAP therapy, and oropharyngeal training (delivered face-to-face or via telerehabilitation). This system aims to enhance clinicians' ability to predict treatment success rates and improve patient outcomes.
Read the detailed description
Backgrounds:
Obstructive sleep apnea syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting about 14% of men and 5% of women aged 30-70 years. The etiology of OSA is divided into anatomical and non-anatomical factors. Anatomical factors include upper airway narrowing or collapse, while non-anatomical factors encompass reduced muscle responsiveness, low arousal threshold, and high loop gain. Anatomical issues can be managed using surgical interventions or dental appliances. Non-anatomical issues like low arousal threshold and high loop gain may require pharmacological treatment or oxygen therapy. The genioglossus (GG) muscle's activity, crucial during sleep, is insufficient in about 30% of OSA patients. Regular oropharyngeal muscle exercises can reduce OSA severity and related symptoms.
However, precise clinical prediction tools for selecting optimal treatment strategies are lacking, and research on telerehabilitation for OSA patients is insufficient. This study aims to develop an automated treatment clustering system using artificial intelligence to classify patients based on etiology into: (i) anatomical factors, (ii) reduced muscle responsiveness, and (iii) other non-anatomical factors. This system will analyze physiological sleep assessments from a retrospective polysomnography (PSG) database. Cross-validation will be conducted on new OSA patients undergoing various management strategies, including surgical intervention, CPAP therapy, and oropharyngeal training (delivered face-to-face or via telerehabilitation).
Methods:
The automated treatment clustering system employs artificial intelligence to classify patients into etiological groups: (i) anatomical factors like upper airway narrowing or collapse; (ii) non-anatomical factors such as reduced muscle responsiveness; and (iii) other non-anatomical factors. The classification relies on analyzing multiple physiological sleep assessments, including electromyography (EMG) and pneumotachographs, from a retrospective PSG database. The system will undergo cross-validation with novel OSA patients, who will be screened based on inclusion and exclusion criteria and provide consent.
During the cross-validation phase, the OSA patients will undergo various assessments, including polysomnography, sleep-related questionnaire, drug-induced sleep endoscopy (DISE), computed tomography (CT) scans, functional magnetic resonance imaging (fMRI), tongue muscle strength and endurance tests, and mental state evaluations. Pre- and post-treatment measurements will be conducted. CT scans and DISE will assess anatomical structures before and after treatment, while fMRI will examine brain activation status. Muscle strength and endurance tests will evaluate the responsiveness level of tongue muscle before and after intervention.
The automated treatment clustering system, utilizing machine learning, will determine the phenotype of each case based on PSG, CT, sleep endoscopy, fMRI, and tongue strength and endurance results. These results will aid clinicians in categorizing patients and predicting treatment success rates. Treatment decisions will involve collaboration between physicians and patients, considering clinical expertise and patient preferences.
Participants classified as upper airway narrowing or collapse due to anatomical factors by the phenotyping system will be recommended for surgical management. For patients with reduced muscle responsiveness, a 12-week program of oropharyngeal muscle training is recommended. This training will be administered in two modes: face-to-face sessions and telerehabilitation. Each session will last 45-60 minutes, with participants attending face-to-face sessions in the lab or online classes (telerehabilitation) 1-3 days per week. Both groups will be instructed to perform additional oropharyngeal exercises at home. Patients not fitting these groups will use CPAP therapy, the gold standard for OSA management. During the treatment period, participants from all groups will have regular follow-ups to assess potential risks. Each group is expected to include 50 cases. After six months of treatment, the apnea-hypopnea index will be collected based on polysomnography to evaluate the success rates, comparing them to the predicted value analyzed using the phenotyping system.
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- Control Group, Surgical Intervention, Oropharyngeal Training (face-to-face), Oropharyngeal Training (telerehabilitation), Continuous Positive Airway Pressure
- Keywords
- Obstructive Sleep Apnea, Treatment Clustering System
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
sleep hygiene education
Surgical InterventionProcedure or surgery
Surgical Intervention includes uvulopalatopharyngoplasty (UPPP) and transoral robotic surgery (TORS). UPPP involves the removal of the uvula and tonsils, while TORS consists of the removal of the uvula, tonsils, and adipose tissue at the base of the tongue.
Oropharyngeal Training (face-to-face)Other
Participants will attend face-to-face oropharyngeal training sessions with a therapist in the lab, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period.
Oropharyngeal Training (telerehabilitation)Other
Participants will attend online oropharyngeal training (telerehabilitation) sessions with a therapist, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period.
Continuous Positive Airway PressureDevice
Participants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | Participants who are unwilling to undergo surgery, use a mandibular advancement device, utilize continuous positive airway pressure (CPAP) devices, or undergo oropharyngeal training. They will receive sleep hygiene education. Receives: Other: Control Group |
| Surgical Intervention | Experimental | Remove excessive soft tissue from the base of the tongue, soft palate, and/or tonsil. Receives: Procedure: Surgical Intervention |
| Oropharyngeal Training (face-to-face) | Experimental | Participants will attend face-to-face oropharyngeal training sessions with a therapist in the lab, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period. Receives: Other: Oropharyngeal Training (face-to-face) |
| Oropharyngeal Training (telerehabilitation ) | Experimental | Participants will attend online oropharyngeal training (telerehabilitation) sessions with a therapist, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period. Receives: Other: Oropharyngeal Training (telerehabilitation) |
| Continuous Positive Airway Pressure | Experimental | Participants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period. Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-hypopnea -index
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, 12 weeks, 24 weeks post intervention
Secondary outcomes (11)
Tongue muscle strength
The maximal muscle strength of genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (kPa)
Measured: Baseline, 12 weeks, 24 weeks post intervention
Tongue muscle endurance
The endurance of the genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (in seconds).
Measured: Baseline, 12 weeks, 24 weeks post intervention
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 cm^3. The minimum score is 0 and a higher score indicates greater in pharyngeal airway volume.
Measured: Baseline, 12 weeks, 24 weeks post intervention
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 cm^2. The minimum score is 0 and a higher score indicates greater in the cross-sectional area of the region.
Measured: Baseline, 12 weeks, 24 weeks post intervention
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, 12 weeks, 24 weeks post intervention
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, 12 weeks, 24 weeks post intervention
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, 12 weeks, 24 weeks post intervention
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, 12 weeks, 24 weeks post intervention
Daytime sleepiness level
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, 12 weeks, 24 weeks post intervention
Activation of brain
Functional MRI (fMRI) will be conducted by psychiatrists to evaluate the activation of brain areas in a relaxed state, including the amygdala, hippocampus, insula, locus coeruleus, ventromedial prefrontal cortex, mammillary bodies, and lateral hypothalamus.
Measured: Baseline, 12 weeks, 24 weeks post intervention
Mental State Assessment
Using the Hospital Anxiety and Depression Scale (HADS) to assess subjects' mood over the past week. HADS. Each subscale has a maximum score of 21, with higher scores indicating greater anxiety or depression.
Measured: Baseline, 12 weeks, 24 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start30 Jul 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-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
- NCT06512779
- Sponsor's protocol ID
- A-BR-109-039
- Status last verified
- Aug 2024
- First submitted
- 16 Jul 2024
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ong JH, Liu CY, Chooi MH, Lin CY, Hung CH. Effectiveness of supervised multilevel oropharyngeal rehabilitation via videoconference on tongue function and apnea severity in obstructive sleep apnea: Quasi-experimental study. Rehabilitacion (Madr). 2026 Jan-Mar;60(1):100963. doi: 10.1016/j.rh.2026.100963. Epub 2026 Feb 23.
PubMed 41734638
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Treatment Clustering System for Obstructive Sleep Apnea Using Polysomnographic Physiological Signals
- ClinicalTrials.gov ID
- NCT06512779
- Acronym / sponsor ID
- A-BR-109-039
- Conditions
- Obstructive Sleep Apnea of Adult
- Keywords
- Obstructive Sleep Apnea, Treatment Clustering System
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 22 Jul 2024 (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 syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting approximately 14% of men and 5% of women aged 30-70 years.
However, precise clinical prediction tools for selecting optimal treatment strategies are lacking. This study aims to develop an automated treatment clustering system using artificial intelligence to classify patients based on etiology into (i) anatomical factors, (ii) reduced muscle responsiveness, and (iii) other non-anatomical factors. This system will analyze physiological sleep assessments, such as electromyography (EMG) and pneumotachographs, from a retrospective polysomnography (PSG) database. Cross-validation will be conducted on new OSA patients undergoing various management strategies, including surgical intervention, CPAP therapy, and oropharyngeal training (delivered face-to-face or via telerehabilitation). This system aims to enhance clinicians' ability to predict treatment success rates and improve patient outcomes.
Detailed description
Backgrounds:
Obstructive sleep apnea syndrome (OSA) is marked by repeated upper airway obstructions during sleep, affecting about 14% of men and 5% of women aged 30-70 years. The etiology of OSA is divided into anatomical and non-anatomical factors. Anatomical factors include upper airway narrowing or collapse, while non-anatomical factors encompass reduced muscle responsiveness, low arousal threshold, and high loop gain. Anatomical issues can be managed using surgical interventions or dental appliances. Non-anatomical issues like low arousal threshold and high loop gain may require pharmacological treatment or oxygen therapy. The genioglossus (GG) muscle's activity, crucial during sleep, is insufficient in about 30% of OSA patients. Regular oropharyngeal muscle exercises can reduce OSA severity and related symptoms.
However, precise clinical prediction tools for selecting optimal treatment strategies are lacking, and research on telerehabilitation for OSA patients is insufficient. This study aims to develop an automated treatment clustering system using artificial intelligence to classify patients based on etiology into: (i) anatomical factors, (ii) reduced muscle responsiveness, and (iii) other non-anatomical factors. This system will analyze physiological sleep assessments from a retrospective polysomnography (PSG) database. Cross-validation will be conducted on new OSA patients undergoing various management strategies, including surgical intervention, CPAP therapy, and oropharyngeal training (delivered face-to-face or via telerehabilitation).
Methods:
The automated treatment clustering system employs artificial intelligence to classify patients into etiological groups: (i) anatomical factors like upper airway narrowing or collapse; (ii) non-anatomical factors such as reduced muscle responsiveness; and (iii) other non-anatomical factors. The classification relies on analyzing multiple physiological sleep assessments, including electromyography (EMG) and pneumotachographs, from a retrospective PSG database. The system will undergo cross-validation with novel OSA patients, who will be screened based on inclusion and exclusion criteria and provide consent.
During the cross-validation phase, the OSA patients will undergo various assessments, including polysomnography, sleep-related questionnaire, drug-induced sleep endoscopy (DISE), computed tomography (CT) scans, functional magnetic resonance imaging (fMRI), tongue muscle strength and endurance tests, and mental state evaluations. Pre- and post-treatment measurements will be conducted. CT scans and DISE will assess anatomical structures before and after treatment, while fMRI will examine brain activation status. Muscle strength and endurance tests will evaluate the responsiveness level of tongue muscle before and after intervention.
The automated treatment clustering system, utilizing machine learning, will determine the phenotype of each case based on PSG, CT, sleep endoscopy, fMRI, and tongue strength and endurance results. These results will aid clinicians in categorizing patients and predicting treatment success rates. Treatment decisions will involve collaboration between physicians and patients, considering clinical expertise and patient preferences.
Participants classified as upper airway narrowing or collapse due to anatomical factors by the phenotyping system will be recommended for surgical management. For patients with reduced muscle responsiveness, a 12-week program of oropharyngeal muscle training is recommended. This training will be administered in two modes: face-to-face sessions and telerehabilitation. Each session will last 45-60 minutes, with participants attending face-to-face sessions in the lab or online classes (telerehabilitation) 1-3 days per week. Both groups will be instructed to perform additional oropharyngeal exercises at home. Patients not fitting these groups will use CPAP therapy, the gold standard for OSA management. During the treatment period, participants from all groups will have regular follow-ups to assess potential risks. Each group is expected to include 50 cases. After six months of treatment, the apnea-hypopnea index will be collected based on polysomnography to evaluate the success rates, comparing them to the predicted value analyzed using the phenotyping system.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Other: Control GroupParticipants who are unwilling to undergo surgery, use a mandibular advancement device, utilize continuous positive airway pressure (CPAP) devices, or undergo oropharyngeal training. They will receive sleep hygiene education. |
| Surgical Intervention | Experimental | Procedure: Surgical InterventionRemove excessive soft tissue from the base of the tongue, soft palate, and/or tonsil. |
| Oropharyngeal Training (face-to-face) | Experimental | Other: Oropharyngeal Training (face-to-face)Participants will attend face-to-face oropharyngeal training sessions with a therapist in the lab, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period. |
| Oropharyngeal Training (telerehabilitation ) | Experimental | Other: Oropharyngeal Training (telerehabilitation)Participants will attend online oropharyngeal training (telerehabilitation) sessions with a therapist, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period. |
| Continuous Positive Airway Pressure | Experimental | Device: Continuous Positive Airway PressureParticipants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- OSA patients
- Aged over 20 years
Key exclusion criteria (11 listed)
- BMI≧ 32
- Central or mixed types of sleep apnea
- A history of malignancy or infection of the head and neck region and laryngeal trauma
- Craniofacial malformation
- Stroke
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 |
|---|---|---|
| Control Groupsleep hygiene education | Other | Control Group |
| Surgical InterventionSurgical Intervention includes uvulopalatopharyngoplasty (UPPP) and transoral robotic surgery (TORS). UPPP involves the removal of the uvula and tonsils, while TORS consists of the removal of the uvula, tonsils, and adipose tissue at the base of the tongue. | Procedure or surgery | Surgical Intervention |
| Oropharyngeal Training (face-to-face)Participants will attend face-to-face oropharyngeal training sessions with a therapist in the lab, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period. | Other | Oropharyngeal Training (face-to-face) |
| Oropharyngeal Training (telerehabilitation)Participants will attend online oropharyngeal training (telerehabilitation) sessions with a therapist, each lasting 45-60 minutes, 1-2 times per week, over a 12-week intervention period. | Other | Oropharyngeal Training (telerehabilitation ) |
| Continuous Positive Airway PressureParticipants will use Continuous Positive Airway Pressure (CPAP) throughout the intervention period. | Device | Continuous Positive Airway Pressure |
Primary outcome
Apnea-hypopnea -index
Time frame: Baseline, 12 weeks, 24 weeks post intervention
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.
11 secondary outcomes
Tongue muscle strength
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Tongue muscle endurance
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Pharyngeal Airway Volume
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Cross Section Area on the Tip of Epiglottis
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Anterior to Posterior Distance on the Tip of the Epiglottis
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Lateral Distance on the Tip of Epiglottis
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Drug-induced Sleep Endoscopy (DISE)
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Sleep Quality
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Daytime sleepiness level
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Activation of brain
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Mental State Assessment
Time frame: Baseline, 12 weeks, 24 weeks post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 41734638Ong JH, Liu CY, Chooi MH, Lin CY, Hung CH. Effectiveness of supervised multilevel oropharyngeal rehabilitation via videoconference on tongue function and apnea severity in obstructive sleep apnea: Quasi-experimental study. Rehabilitacion (Madr). 2026 Jan-Mar;60(1):100963. doi: 10.1016/j.rh.2026.100963. Epub 2026 Feb 23.
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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. This study is not recruiting at the moment.
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 Surgical Intervention, Oropharyngeal Training (face-to-face) and Oropharyngeal Training (telerehabilitation) 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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. 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?
Results are not available in the source record.
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?
Apnea-hypopnea -index (time frame: Baseline, 12 weeks, 24 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06512779, which also lists 1 linked publication.
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 6 Aug 2024.