Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huang Kang Ku
- Phone Number: +886955006113
- Email: a0955006113@gmail.com
Study Locations
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Tainan, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital
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Contact:
- Ching-Hsia Hung, Ph.D
- Phone Number: 5939 06-2353535
- Email: chhung@mail.ncku.edu.tw
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: intervention group
We conducted a once a week, 12-week-intervention of Oropharyngeal Exercises and Mandibular advancement device
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Oropharyngeal Exercises
|
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Sham Comparator: control group
Mandibular advancement device
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Oropharyngeal Exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Apnea-hypopnea -index
Time Frame: Baseline to 12 weeks
|
Assessed 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)
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Baseline to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tongue muscle strength
Time Frame: Baseline to 12 weeks
|
The maximal muscle strength of genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (kPa)
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Baseline to 12 weeks
|
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Tongue muscle endurance
Time Frame: Baseline to 12 weeks
|
The endurance of the genioglossus muscles using The Iowa Oral Performance Instrument (IOPI) system, model 2.2 (Northwest, Co., LLC, Carnation, WA, USA) (in seconds)
|
Baseline to 12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Ching Hsia Hung, PhD, National Cheng Kung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-ER-111-222
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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