Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05717959
Study type	Interventional
Source	National Cheng-Kung University Hospital
Contact	Huang Kang Ku
Phone	+886955006113
Email	a0955006113@gmail.com
Status	Recruiting
Phase	N/A
Start date	September 2, 2022
Completion date	December 31, 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms