Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure
NCT ID: NCT06999746
Last Updated: 2025-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-06-15
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sleep hygiene education
Receive monthly sleep hygiene education
Control
Sleep hygiene education
Oropharyngeal rehabilitation
Receive oropharyngeal rehabilitation training over three months
Oropharyngeal Exercise
Device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Continuous positive airway pressure
Receive continuous positive airway pressure
Continuous positive airway pressure
Continuous positive airway pressure, 1-5 days a week for three months
Continuous positive airway pressure and oropharyngeal rehabilitation
Receive continuous positive airway pressure and oropharyngeal rehabilitation training for three months
Continuous positive airway pressure and oropharyngeal exercise
Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Control
Sleep hygiene education
Oropharyngeal Exercise
Device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Continuous positive airway pressure
Continuous positive airway pressure, 1-5 days a week for three months
Continuous positive airway pressure and oropharyngeal exercise
Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Newly diagnosed with mild to severe pure obstructive sleep apnea based on polysomnography
Exclusion Criteria
* 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
20 Years
68 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cheng-Kung University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ching-Hsia Hung, PhD
Role: PRINCIPAL_INVESTIGATOR
National Cheng Kung University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National Cheng Kung University Hospital
Tainan City, , Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Ching-Hsia Hung, PhD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
B-BR-113-050
Identifier Type: -
Identifier Source: org_study_id