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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：
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep hygiene education | Sham Comparator | Receive monthly sleep hygiene education |
|
| Oropharyngeal rehabilitation | Experimental | Receive oropharyngeal rehabilitation training over three months |
|
| Continuous positive airway pressure | Experimental | Receive continuous positive airway pressure |
|
| Continuous positive airway pressure and oropharyngeal rehabilitation | Experimental | Receive continuous positive airway pressure and oropharyngeal rehabilitation training for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Sleep hygiene education |
| |
| Oropharyngeal Exercise |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline and 12 weeks post intervention |
| Tongue Muscle Endurance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chieh-Yu Liu, MS | Contact | +886-988-613-312 | chiehyu0506@gmail.com | |
| Ching-Hsia Hung, PhD | Contact | +886-6-2353535 | 5939 | chhung@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Ching-Hsia Hung, PhD | National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
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| Device |
Device-monitoring oropharyngeal exercise, 1-5 days a week for three months |
|
| Continuous positive airway pressure | Device | Continuous positive airway pressure, 1-5 days a week for three months |
|
| Continuous positive airway pressure and oropharyngeal exercise | Device | Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months |
|
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). |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months |
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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