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

Sponsor
National Cheng-Kung University Hospital
Study ID
NCT06999746
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
20 Years - 68 Years
Healthy Volunteers
Not accepted

Interventions

  • Control — OTHER
    Sleep hygiene education
  • Oropharyngeal Exercise — 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

Study Details

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.

Key Dates

First listed
May 31, 2025
Start date
Jun 15, 2025
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sleep hygiene education
    Receive monthly sleep hygiene education
  • Experimental: Oropharyngeal rehabilitation
    Receive oropharyngeal rehabilitation training over three months
  • Experimental: Continuous positive airway pressure
    Receive continuous positive airway pressure
  • Experimental: Continuous positive airway pressure and oropharyngeal rehabilitation
    Receive continuous positive airway pressure and oropharyngeal rehabilitation training for three months

Primary Outcome Measure

Apnea-Hypopnea Index [ Time Frame: Baseline and 12 weeks post intervention ]

Central Contacts

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