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

NCT ID: NCT05717959

Last Updated: 2024-03-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-02
• Study Completion Date: 2024-12-31

Brief Summary

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.

Detailed 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

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

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

Group Type: EXPERIMENTAL

Oropharyngeal Exercises

Intervention Type: BEHAVIORAL

Oropharyngeal Exercises

control group

Mandibular advancement device

Group Type: SHAM_COMPARATOR

Oropharyngeal Exercises

Intervention Type: BEHAVIORAL

Oropharyngeal Exercises

Interventions

Oropharyngeal Exercises

Oropharyngeal Exercises

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching Hsia Hung, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng Kung University

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Huang Kang Ku

Role: CONTACT

a0955006113@gmail.com

+886955006113

Facility Contacts

Ching-Hsia Hung, Ph.D

Role: primary

chhung@mail.ncku.edu.tw

06-2353535 ext. 5939

Other Identifiers

B-ER-111-222

Identifier Type: -

Identifier Source: org_study_id