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

NCT06999746 | Not Yet Recruiting

• 1 other identifier: B-BR-113-050
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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. 1.Does combining OPR with CPAP increase upper airway space volume compared to using CPAP alone?
2. 2.Does OPR improve tongue muscle strength, and is this improvement associated with reduced CPAP pressure requirements?
3. 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.
4. 4.Be randomly assigned to one of four groups (Control, OPR-only, CPAP-only, CPAP+OPR).
5. 5.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.
6. 6.Have their exercise monitored using a strength sensor, with intensity adjusted every 2-4 weeks during hospital visits.
7. 7.Undergo assessments before and after the intervention, including:

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

• Tongue Muscle Strength

  Baseline and 12 weeks post intervention

• Tongue Muscle Endurance

  Baseline and 12 weeks post intervention

• Pharyngeal Airway Volume

  Baseline and 12 weeks post intervention

• Cross Section Area on the Tip of Epiglottis

  Baseline and 12 weeks post intervention

• Anterior to Posterior Distance on the Tip of the Epiglottis

  Baseline and 12 weeks post intervention

Study Arms (4)

Sleep hygiene education

SHAM COMPARATOR

Receive monthly sleep hygiene education

Other: Control

Oropharyngeal rehabilitation

EXPERIMENTAL

Receive oropharyngeal rehabilitation training over three months

Device: Oropharyngeal Exercise

Continuous positive airway pressure

EXPERIMENTAL

Receive continuous positive airway pressure

Device: Continuous positive airway pressure

Continuous positive airway pressure and oropharyngeal rehabilitation

EXPERIMENTAL

Receive continuous positive airway pressure and oropharyngeal rehabilitation training for three months

Device: Continuous positive airway pressure and oropharyngeal exercise

Interventions

Control OTHER

Sleep hygiene education

Sleep hygiene education

Oropharyngeal Exercise DEVICE

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

Oropharyngeal rehabilitation

Continuous positive airway pressure DEVICE

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

Continuous positive airway pressure

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

Continuous positive airway pressure and oropharyngeal rehabilitation

Eligibility Criteria

• Age: 20 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Ching-Hsia Hung, PhD

  National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chieh-Yu Liu, MS

CONTACT

+886-988-613-312; chiehyu0506@gmail.com

Ching-Hsia Hung, PhD

CONTACT

+886-6-2353535; chhung@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)