Clinical trial NCT06999746: Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure
Official title: Effectiveness of Using Force Sensing Resistor to Assist Oropharyngeal Rehabilitation in Patients With Obstructive Sleep Apnea Using Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 200
Sex: ALL
Minimum age (years): 20
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

The main questions it aims to answer are:

1. Does combining OPR with CPAP increase upper airway space volume compared to using CPAP alone?
2. Does OPR improve tongue muscle strength, and is this improvement associated with reduced CPAP pressure requirements?
3. 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:

1. Be randomly assigned to one of four groups (Control, OPR-only, CPAP-only, CPAP+OPR).
2. 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.
3. Have their exercise monitored using a strength sensor, with intensity adjusted every 2-4 weeks during hospital visits.
4. 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：

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 20 to 68 years
* Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: Baseline and 12 weeks post intervention
Secondary outcomes:
measure: Tongue Muscle Strength
timeFrame: Baseline and 12 weeks post intervention
measure: Tongue Muscle Endurance
timeFrame: Baseline and 12 weeks post intervention
measure: Pharyngeal Airway Volume
timeFrame: Baseline and 12 weeks post intervention
measure: Cross Section Area on the Tip of Epiglottis
timeFrame: Baseline and 12 weeks post intervention
measure: Anterior to Posterior Distance on the Tip of the Epiglottis
timeFrame: Baseline and 12 weeks post intervention
measure: Lateral Distance on the Tip of Epiglottis
timeFrame: Baseline and 12 weeks post intervention
measure: Sleep Quality
timeFrame: Baseline and 12 weeks post intervention
measure: Daytime Sleepiness Level
timeFrame: Baseline and 12 weeks post intervention
measure: Tongue Muscle Thickness
timeFrame: Baseline and 12 weeks post intervention
measure: Median Pressure in Continuous Positive Airway Pressure
timeFrame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
measure: Median Usage Hours of Continuous Positive Airway Pressure
timeFrame: 1-week average pre intervention, 1-week average post intervention and 1-month average during intervention for 3 months
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng Kung University
name: Ching-Hsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: