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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05717959
Enrollment
20
Registered
2023-02-08
Start date
2022-09-02
Completion date
2024-12-31
Last updated
2024-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Obstructive Sleep Apnea, Mandibular advancement device, oropharyngeal exercises

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

Interventions

Oropharyngeal Exercises

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Apnea-hypopnea -indexBaseline to 12 weeksAssessed using Polysomnography (PSG). The average apnea and hypopnea events per hour, oxygen saturation index and the snoring index will be obtained during the sleep test(PSG)

Secondary

MeasureTime frameDescription
Tongue muscle strengthBaseline to 12 weeksThe maximal muscle strength of genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (kPa)
Tongue muscle enduranceBaseline to 12 weeksThe endurance of the genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (in seconds)

Countries

Taiwan

Contacts

Primary ContactHuang Kang Ku
a0955006113@gmail.com+886955006113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026