An interventional study of Control and Oropharyngeal Exercise in Obstructive Sleep Apnea, sponsored by National Cheng-Kung University Hospital. Not yet recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 68 Years. Per ClinicalTrials.gov, last updated 2025-05-31.
Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment
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:
Participants will:
(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.
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：
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's planned enrollment of 200 is above the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →National Cheng-Kung University Hospital is the lead sponsor of 276 studies on the registry; 71 are open to participants now.
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Exclusion Criteria:
Receive monthly sleep hygiene education
Other: Control
Receive oropharyngeal rehabilitation training over three months
Device: Oropharyngeal Exercise
Receive continuous positive airway pressure
Device: Continuous positive airway pressure
Receive continuous positive airway pressure and oropharyngeal rehabilitation training for three months
Device: Continuous positive airway pressure and oropharyngeal exercise
Sleep hygiene education
Device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Continuous positive airway pressure, 1-5 days a week for three months
Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months
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.
Time frame: Baseline and 12 weeks post intervention
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)
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2025; primary completion for Dec 2028, 42 months later.
Of 511 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 42 months is above that.
Counting every sponsor, half of 621 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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