Back to resultsImpact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
myofunctional therapy program
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring myofunctional therapy, IOPI, Obstructive sleep apnea (OSA)
Eligibility Criteria
Inclusion Criteria:
- Patients who diagnose with Obstructive sleep apnea 18-65 years
Exclusion Criteria:
- BMI>=35kg/m2
- alcoholic and smoke
- use sleeping pill
- craniofacial syndrome
- hypertrophic tonsils grade 3+, 4+
- severe comorbidity
- Use CAP
Sites / Locations
- Rajavithi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Obstructive sleep apnea
control
Arm Description
myofunctional therapy program
standard treatment
Outcomes
Primary Outcome Measures
Compare muscle strength
compare muscle strength before and after program by IOPI
Secondary Outcome Measures
Full Information
NCT ID
NCT05043389
First Posted
September 5, 2021
Last Updated
September 21, 2021
Sponsor
Rajavithi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05043389
Brief Title
Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea
Official Title
Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea: a Randomized Controlled Trail
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This Research studies for compare muscle strength among OSA patients who treat with myofunctional therapy program in Rajavithi hospital
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
myofunctional therapy, IOPI, Obstructive sleep apnea (OSA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Obstructive sleep apnea
Arm Type
Experimental
Arm Description
myofunctional therapy program
Arm Title
control
Arm Type
No Intervention
Arm Description
standard treatment
Intervention Type
Other
Intervention Name(s)
myofunctional therapy program
Intervention Description
Exercise oral cavity muscle
Primary Outcome Measure Information:
Title
Compare muscle strength
Description
compare muscle strength before and after program by IOPI
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who diagnose with Obstructive sleep apnea 18-65 years
Exclusion Criteria:
BMI>=35kg/m2
alcoholic and smoke
use sleeping pill
craniofacial syndrome
hypertrophic tonsils grade 3+, 4+
severe comorbidity
Use CAP
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sasion Phaibunphunphiphat, MD
Phone
0831669009
Email
sasiorn_p@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sasikarn Poomkonsarn, MD
Phone
0899444293
Email
scapnetent@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sasion Phaibunphunphiphat, MD
Organizational Affiliation
Rajavithi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajavithi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sasion Phaibunphunphiphat, MD
Phone
0819066659
Email
sasiorn_p@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea
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