Obstructive Sleep ApneaNCT06999746
Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure
A study testing Oropharyngeal Exercise, Continuous positive airway pressure and Continuous positive airway pressure and oropharyngeal exercise in people with Obstructive Sleep Apnea, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of device-assisted oropharyngeal rehabilitation (OPR) in improving upper airway muscle function and reducing obstructive sleep apnea (OSA) severity in adult patients diagnosed with OSA who are receiving continuous positive airway pressure (CPAP) therapy. Read more about this study
- Who is it for?
- Ages 20 to 68 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Oropharyngeal Exercise, Continuous positive airway pressure and Continuous positive airway pressure and oropharyngeal exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Jun 2025to 31 Dec 2029
- 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 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 68 years
- Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography
Who cannot join
- Severe allergic rhinitis
- Sinusitis with nasal polyps
- Adenoid hypertrophy
- Bilateral tonsillar hypertrophy (Friedman grade ≥ III)
- Lingual tonsil hypertrophy (Friedman grade ≥ III)
- Body Mass Index (BMI) > 40
Show all 14Show fewer
- Alcohol or drug abuse within the past year
- Pregnancy
- Severe obstructive or restrictive pulmonary diseases
- High-risk cardiovascular diseases during exercise (e.g., angina, myocardial infarction, heart failure, valvular heart disease)
- History of central or peripheral neurological disorders that interfere with exercise prescription
- Musculoskeletal or psychological disorders that interfere with exercise prescription
- Other non-respiratory sleep disorders
- Sleep disorders with concomitant central sleep apnea
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
National Cheng Kung University Hospital
Tainan, 704
Ching-Hsia Hung, PhD, +886-6-2353535 ext. 5939, chhung@mail.ncku.edu.tw
About this study
Official title: Effectiveness of Using Force Sensing Resistor to Assist Oropharyngeal Rehabilitation in Patients With Obstructive Sleep Apnea Using Continuous Positive Airway Pressure
The goal of this clinical trial is to evaluate the effectiveness of device-assisted oropharyngeal rehabilitation (OPR) in improving upper airway muscle function and reducing obstructive sleep apnea (OSA) severity in adult patients diagnosed with OSA who are receiving continuous positive airway pressure (CPAP) therapy.
The main questions it aims to answer are:
Read more
- Does combining OPR with CPAP increase upper airway space volume compared to using CPAP alone?
- Does OPR improve tongue muscle strength, and is this improvement associated with reduced CPAP pressure requirements?
- Do patients receiving OPR (alone or combined with CPAP) show greater improvements in OSA severity and clinical symptoms compared to those receiving CPAP alone or no intervention? Researchers will compare four groups-Control, OPR-only, CPAP-only, and CPAP + OPR-to see if device-assisted OPR enhances treatment outcomes beyond CPAP alone.
Participants will:
- Be randomly assigned to one of four groups (Control, OPR-only, CPAP-only, CPAP+OPR).
- Perform home-based OPR exercises (30-45 minutes/session, 1-2 sessions/day, 3-5 days/week for 3 months) in the OPR and CPAP+OPR groups.
- Have their exercise monitored using a strength sensor, with intensity adjusted every 2-4 weeks during hospital visits.
- Undergo assessments before and after the intervention, including: (1) Polysomnography for OSA severity, (2) CT and ultrasound for upper airway and tongue muscle structure, (3) Tongue muscle strength/endurance tests, (4) Sleep quality questionnaires, (5) CPAP usage and pressure reports.
Read the detailed description
Background: Obstructive sleep apnea (OSA) is a common respiratory disorder associated with various complications, including cardiovascular, metabolic, and cognitive issues. Continuous positive airway pressure (CPAP) therapy can effectively reduce sleep apnea events and decrease the incidence of related complications. However, studies have shown that approximately half of OSA patients attempting CPAP therapy either cannot tolerate CPAP at all or only partially comply with it. Oropharyngeal rehabilitation (OPR), which involves isometric and isotonic exercises, can enhance the muscle tone of the tongue, pharynx, and soft palate. OPR may serve as one of the treatment options for OSA. Nevertheless, there is limited literature exploring the combined treatment approach of CPAP and OPR.
Methods：This study will recruit 30 200 adult OSA patients, who will be divided into two four groups: Control, OPR, CPAP alone and CPAP+OPR. The OPR training in OPR and CPAP+OPR groups will consist of home-based exercises performed for 30-45 minutes per session, once 1-2 session a day, five 3-5 days a week, over a period of three months. The training will be monitored using a strength sensor, and the intensity of the exercises will be adjusted every two weeks month during hospital visits. Both CPAP and CPAP+OPR groups will continue to wear CPAP every night, while the control group will receive monthly sleep hygiene education. The severity of OSA, upper airway space, tongue muscle length/thickness, tongue muscle strength/endurance, sleep quality, and CPAP usage report will be assessed using polysomnography, computed tomography scans, sonography, tongue muscle function tests, sleep quality questionnaires, and CPAP mask pressure at baseline and after three months of treatment.
Expected outcomes：
- Compared to the group using only CPAP, the CPAP + OPR group will have an increased upper airway space volume after a 3-month follow-up. The upper airway space volume is negatively correlated with CPAP pressure and positively correlated with tongue muscle strength.
- After 3 months of OPR treatment, the CPAP + OPR group will show an increase in tongue muscle strength, which is negatively correlated with CPAP pressure.
- After 3 months of OPR treatment, both the OPR group and the CPAP+OPR group showed greater improvements in upper airway muscle function and greater reductions in obstructive sleep apnea severity and clinical symptoms compared to the control group and the CPAP group respectively.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Control, Oropharyngeal Exercise, Continuous positive airway pressure, Continuous positive airway pressure and oropharyngeal exercise
- 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.
ControlOther
Sleep hygiene education
Oropharyngeal ExerciseDevice
Device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Continuous positive airway pressureDevice
Continuous positive airway pressure, 1-5 days a week for three months
Continuous positive airway pressure and oropharyngeal exerciseDevice
Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months
| Study group | Role | What they receive |
|---|---|---|
| Sleep hygiene education | Sham comparator | Receive monthly sleep hygiene education Receives: Other: Control |
| Oropharyngeal rehabilitation | Experimental | Receive oropharyngeal rehabilitation training over three months Receives: Device: Oropharyngeal Exercise |
| Continuous positive airway pressure | Experimental | Receive continuous positive airway pressure Receives: Device: Continuous positive airway pressure |
| Continuous positive airway pressure and oropharyngeal rehabilitation | Experimental | Receive continuous positive airway pressure and oropharyngeal rehabilitation training for three months Receives: Device: Continuous positive airway pressure and oropharyngeal exercise |
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 and 12 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 and 12 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 and 12 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 and 12 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 and 12 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 and 12 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 and 12 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 and 12 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 and 12 weeks post intervention
Tongue Muscle Thickness
Sonography will be performed over the participant's neck region to assess the changes in tongue muscle thickness during normal breathing and Müller's maneuver. The data on tongue thickness will be presented in millimeters. A greater value indicates a thicker in tongue.
Measured: Baseline and 12 weeks post intervention
Median Pressure in Continuous Positive Airway Pressure
The change in therapeutic CPAP pressure required to maintain airway patency will be assessed using CPAP usage reports. A reduction in required pressure is expected to indicate improved upper airway muscle tone and stability.
Measured: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Median Usage Hours of Continuous Positive Airway Pressure
The average number of hours per night that participants use CPAP will be recorded from CPAP usage reports. Greater nightly usage is considered indicative of better compliance and treatment effectiveness.
Measured: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 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
- NCT06999746
- Sponsor's protocol ID
- B-BR-113-050
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 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 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Force Sensing Resistor to Assist Oropharyngeal Rehabilitation in Patients With Obstructive Sleep Apnea Using Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT06999746
- Acronym / sponsor ID
- B-BR-113-050
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 31 May 2025 (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.
The goal of this clinical trial is to evaluate the effectiveness of device-assisted oropharyngeal rehabilitation (OPR) in improving upper airway muscle function and reducing obstructive sleep apnea (OSA) severity in adult patients diagnosed with OSA who are receiving continuous positive airway pressure (CPAP) therapy.
The main questions it aims to answer are:
- Does combining OPR with CPAP increase upper airway space volume compared to using CPAP alone?
- Does OPR improve tongue muscle strength, and is this improvement associated with reduced CPAP pressure requirements?
- Do patients receiving OPR (alone or combined with CPAP) show greater improvements in OSA severity and clinical symptoms compared to those receiving CPAP alone or no intervention? Researchers will compare four groups-Control, OPR-only, CPAP-only, and CPAP + OPR-to see if device-assisted OPR enhances treatment outcomes beyond CPAP alone.
Participants will:
- Be randomly assigned to one of four groups (Control, OPR-only, CPAP-only, CPAP+OPR).
- Perform home-based OPR exercises (30-45 minutes/session, 1-2 sessions/day, 3-5 days/week for 3 months) in the OPR and CPAP+OPR groups.
- Have their exercise monitored using a strength sensor, with intensity adjusted every 2-4 weeks during hospital visits.
- Undergo assessments before and after the intervention, including: (1) Polysomnography for OSA severity, (2) CT and ultrasound for upper airway and tongue muscle structure, (3) Tongue muscle strength/endurance tests, (4) Sleep quality questionnaires, (5) CPAP usage and pressure reports.
Detailed description
Background: Obstructive sleep apnea (OSA) is a common respiratory disorder associated with various complications, including cardiovascular, metabolic, and cognitive issues. Continuous positive airway pressure (CPAP) therapy can effectively reduce sleep apnea events and decrease the incidence of related complications. However, studies have shown that approximately half of OSA patients attempting CPAP therapy either cannot tolerate CPAP at all or only partially comply with it. Oropharyngeal rehabilitation (OPR), which involves isometric and isotonic exercises, can enhance the muscle tone of the tongue, pharynx, and soft palate. OPR may serve as one of the treatment options for OSA. Nevertheless, there is limited literature exploring the combined treatment approach of CPAP and OPR.
Methods：This study will recruit 30 200 adult OSA patients, who will be divided into two four groups: Control, OPR, CPAP alone and CPAP+OPR. The OPR training in OPR and CPAP+OPR groups will consist of home-based exercises performed for 30-45 minutes per session, once 1-2 session a day, five 3-5 days a week, over a period of three months. The training will be monitored using a strength sensor, and the intensity of the exercises will be adjusted every two weeks month during hospital visits. Both CPAP and CPAP+OPR groups will continue to wear CPAP every night, while the control group will receive monthly sleep hygiene education. The severity of OSA, upper airway space, tongue muscle length/thickness, tongue muscle strength/endurance, sleep quality, and CPAP usage report will be assessed using polysomnography, computed tomography scans, sonography, tongue muscle function tests, sleep quality questionnaires, and CPAP mask pressure at baseline and after three months of treatment.
Expected outcomes：
- Compared to the group using only CPAP, the CPAP + OPR group will have an increased upper airway space volume after a 3-month follow-up. The upper airway space volume is negatively correlated with CPAP pressure and positively correlated with tongue muscle strength.
- After 3 months of OPR treatment, the CPAP + OPR group will show an increase in tongue muscle strength, which is negatively correlated with CPAP pressure.
- After 3 months of OPR treatment, both the OPR group and the CPAP+OPR group showed greater improvements in upper airway muscle function and greater reductions in obstructive sleep apnea severity and clinical symptoms compared to the control group and the CPAP group respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sleep hygiene education | Sham comparator | Other: ControlReceive monthly sleep hygiene education |
| Oropharyngeal rehabilitation | Experimental | Device: Oropharyngeal ExerciseReceive oropharyngeal rehabilitation training over three months |
| Continuous positive airway pressure | Experimental | Device: Continuous positive airway pressureReceive continuous positive airway pressure |
| Continuous positive airway pressure and oropharyngeal rehabilitation | Experimental | Device: Continuous positive airway pressure and oropharyngeal exerciseReceive continuous positive airway pressure and oropharyngeal rehabilitation training for three months |
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults aged 20 to 68 years
- Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography
Key exclusion criteria (14 listed)
- Severe allergic rhinitis
- Sinusitis with nasal polyps
- Adenoid hypertrophy
- Bilateral tonsillar hypertrophy (Friedman grade ≥ III)
- Lingual tonsil hypertrophy (Friedman grade ≥ III)
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 |
|---|---|---|
| ControlSleep hygiene education | Other | Sleep hygiene education |
| Oropharyngeal ExerciseDevice-monitoring oropharyngeal exercise, 1-5 days a week for three months | Device | Oropharyngeal rehabilitation |
| Continuous positive airway pressureContinuous positive airway pressure, 1-5 days a week for three months | Device | Continuous positive airway pressure |
| Continuous positive airway pressure and oropharyngeal exerciseContinuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months | Device | Continuous positive airway pressure and oropharyngeal rehabilitation |
Primary outcome
Apnea-Hypopnea Index
Time frame: Baseline and 12 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 and 12 weeks post intervention
Tongue Muscle Endurance
Time frame: Baseline and 12 weeks post intervention
Pharyngeal Airway Volume
Time frame: Baseline and 12 weeks post intervention
Cross Section Area on the Tip of Epiglottis
Time frame: Baseline and 12 weeks post intervention
Anterior to Posterior Distance on the Tip of the Epiglottis
Time frame: Baseline and 12 weeks post intervention
Lateral Distance on the Tip of Epiglottis
Time frame: Baseline and 12 weeks post intervention
Sleep Quality
Time frame: Baseline and 12 weeks post intervention
Daytime Sleepiness Level
Time frame: Baseline and 12 weeks post intervention
Tongue Muscle Thickness
Time frame: Baseline and 12 weeks post intervention
Median Pressure in Continuous Positive Airway Pressure
Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Median Usage Hours of Continuous Positive Airway Pressure
Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
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 31 May 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 Oropharyngeal Exercise, Continuous positive airway pressure and Continuous positive airway pressure and oropharyngeal exercise in people with Obstructive Sleep Apnea, 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 14 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: opening soon, as of the sponsor's last update on 31 May 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 Chieh-Yu Liu, MS (+886-988-613-312, chiehyu0506@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 and 12 weeks post intervention). 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 31 May 2025.