Impact of Myofuntional Therapy Program on Increasing Tong... | NCT05043389

Studies
Impact of Myofuntional Therapy Program on Increasing Tongue Strength and Improving Sleep Apnea

NCT05043389

Sponsor

Department of Medical Services Ministry of Public Health of Thailand

Status

Completed

Last Update Posted

Jan 25, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

myofunctional therapy program

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2022Actual

First Submitted Date

Sep 5, 2021

First Submission Date that Met QC Criteria

Sep 5, 2021

First Posted Date

Sep 14, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2024

Last Update Posted Date

Jan 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This Research studies for compare muscle strength among OSA patients who treat with myofunctional therapy program in Rajavithi hospital

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obstructive sleep apnea	Experimental	myofunctional therapy program	Other: myofunctional therapy program
control	No Intervention	standard treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
myofunctional therapy program	Other	Exercise oral cavity muscle	Obstructive sleep apnea

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare muscle strength	compare muscle strength before and after program by IOPI	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sasion Phaibunphunphiphat, MD	Department of Medical Services Ministry of Public Health of Thailand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rajavithi Hospital		Bangkok		10400	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided