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Device-Assisted Oropharyngeal Rehabilitation in Obstructive Sleep Apnea Patients Using Continuous Positive Airway Pressure

NCT06999746 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-05-31

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Control

Sleep hygiene education

DEVICE

Oropharyngeal Exercise

Device-monitoring oropharyngeal exercise, 1-5 days a week for three months

DEVICE

Continuous positive airway pressure

Continuous positive airway pressure, 1-5 days a week for three months

DEVICE

Continuous positive airway pressure and oropharyngeal exercise

Continuous positive airway pressure and device-monitoring oropharyngeal exercise, 1-5 days a week for three months

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Ching-Hsia Hung, PhD · National Cheng Kung University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
68 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-15
Primary Completion
2028-12-31
Completion
2029-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06999746 on ClinicalTrials.gov