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

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Oropharyngeal Exercises
Sponsored by
National Cheng-Kung University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult focused on measuring Obstructive Sleep Apnea, Mandibular advancement device, oropharyngeal exercises

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cheng Kung University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

intervention group

control group

Arm Description

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

Mandibular advancement device

Outcomes

Primary Outcome Measures

Apnea-hypopnea -index
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)

Secondary Outcome Measures

Tongue muscle strength
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)
Tongue muscle endurance
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)

Full Information

First Posted
December 1, 2022
Last Updated
February 6, 2023
Sponsor
National Cheng-Kung University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05717959
Brief Title
Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
Official Title
Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 2, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Adult
Keywords
Obstructive Sleep Apnea, Mandibular advancement device, oropharyngeal exercises

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
We conducted a once a week, 12-week-intervention of Oropharyngeal Exercises and Mandibular advancement device
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Mandibular advancement device
Intervention Type
Behavioral
Intervention Name(s)
Oropharyngeal Exercises
Intervention Description
Oropharyngeal Exercises
Primary Outcome Measure Information:
Title
Apnea-hypopnea -index
Description
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)
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Tongue muscle strength
Description
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)
Time Frame
Baseline to 12 weeks
Title
Tongue muscle endurance
Description
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)
Time Frame
Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huang Kang Ku
Phone
+886955006113
Email
a0955006113@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ching Hsia Hung, PhD
Organizational Affiliation
National Cheng Kung University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ching-Hsia Hung, Ph.D
Phone
06-2353535
Ext
5939
Email
chhung@mail.ncku.edu.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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