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

National Cheng-Kung University

Status: Not yet enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Device: Continuous positive airway pressure and oropharyngeal exercise; Other: Control; Device: Continuous positive airway pressure; Device: Oropharyngeal Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06999746

B-BR-113-050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

Sleep hygiene education

Sham Comparator group

Description:

Receive monthly sleep hygiene education

Treatment:

Other: Control

Oropharyngeal rehabilitation

Experimental group

Description:

Receive oropharyngeal rehabilitation training over three months

Treatment:

Device: Oropharyngeal Exercise

Continuous positive airway pressure

Experimental group

Description:

Receive continuous positive airway pressure

Treatment:

Device: Continuous positive airway pressure

Continuous positive airway pressure and oropharyngeal rehabilitation

Experimental group

Description:

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

Treatment:

Device: Continuous positive airway pressure and oropharyngeal exercise