Efficacy of Oropharyngeal Exercises for Patients With Obstructive Sleep Apnea Using Mandibular Advancement Device
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2022
CompletedFirst Submitted
Initial submission to the registry
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 21, 2024
March 1, 2024
1.9 years
December 1, 2022
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Baseline to 12 weeks
Secondary Outcomes (2)
Tongue muscle strength
Baseline to 12 weeks
Tongue muscle endurance
Baseline to 12 weeks
Study Arms (2)
intervention group
EXPERIMENTALWe conducted a once a week, 12-week-intervention of Oropharyngeal Exercises and Mandibular advancement device
control group
SHAM COMPARATORMandibular advancement device
Interventions
Eligibility Criteria
You may qualify if:
- OSA patients
- aged over 20 years old
- wearing a MAD
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 704, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ching Hsia Hung, PhD
National Cheng Kung University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2022
First Posted
February 8, 2023
Study Start
September 2, 2022
Primary Completion
July 31, 2024
Study Completion
December 31, 2024
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share