Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device

National Cheng-Kung University

Status: Enrolling

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Behavioral: Oropharyngeal Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT05717959

B-ER-111-222

Details and patient eligibility

About

Combined treatment with MAD and OE for adult patients with obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea.

Full description

Background: Obstructive Sleep Apnea (OSA) is a sleeping disorder with recurrent upper airway obstruction during sleep. Patients with OSA often suffer from daytime sleepiness, snoring, and interrupted breathing during sleep. The etiology of OSA can divide into anatomical causes, including narrow, crowded, or easily collapsible upper airway, and non-anatomical causes, including low respiratory arousal threshold, ineffective or reduced pharyngeal dilator muscle activity during sleep, and unstable ventilatory control. A mandibular advancement device (MAD) is one of the treatment options for mild to moderate OSA patients. Oropharyngeal exercises (OE) are a novel intervention targeted at internal/external tongue muscle training with significant improvements in the muscle tension and severity of OSA. The efficacy of combined treatment with MAD and OE has not been investigated. Thus, the present study aims to determine the effectiveness of combing MAD and OE by assessing the tongue function and severity of OSA in patients with OSA.

Methods: A total of 20 participants using MAD for OSA were included in the study. Participants will be divided into two groups: the treatment group with the 12-week OE. OE consists of one to three times 30-minute sessions per day, 3 to 5 days per week for 12 weeks. The weekly clinic visits are required to adjust the intensity of the home exercise program and monitor the training progress. The participants in two groups will receive polysomnography (PSG) test, tongue muscle strength, and endurance testing, at baseline and after the intervention.

Expected results: Combined treatment with MAD and OE for adult patients with mild to moderate obstructive sleep apnea can significantly (i) improve muscle strength and endurance; (ii) reduce the severity of sleep apnea

Enrollment: 20 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OSA patients
• aged over 20 years old
• wearing a MAD

Exclusion criteria

• Body Mass Index (BMI) ≧ 35
• Pregnancy
• Severe obstructive or restrictive lung disease
• Exercise with high-risk cardiovascular disease
• History of central or peripheral neurological disease resulting in an inability to perform exercise prescriptions
• Musculoskeletal or psychological disorders that prevent the performance of exercise prescriptions
• Chronic illnesses that are ongoing or not yet controlled

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

intervention group

Experimental group

Description:

We conducted a once a week, 12-week-intervention of Oropharyngeal Exercises and Mandibular advancement device

Treatment:

Behavioral: Oropharyngeal Exercises

control group

Sham Comparator group

Description:

Mandibular advancement device

Treatment:

Behavioral: Oropharyngeal Exercises