UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041356 |
|---|---|
| Receipt number | R000047216 |
| Scientific Title | The effects of myofunctional therapy in pediatric obstructive sleep apnea, prospective study. |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2026/02/11 11:37:57 |
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Basic information
Public title
The effects of myofunctional therapy in pediatric obstructive sleep apnea, prospective study.
Acronym
Myofunctional therapy in pediatric obstructive sleep apnea.
Scientific Title
The effects of myofunctional therapy in pediatric obstructive sleep apnea, prospective study.
Scientific Title:Acronym
Myofunctional therapy in pediatric obstructive sleep apnea.
Region
| Japan |
Condition
Condition
Obstructive sleep apnea
Classification by specialty
| Oto-rhino-laryngology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effectiveness of myofunctional therapy in pediatric obstructive sleep apnea.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Severity of obstructive sleep apnea, tongue pressure and nasal flow
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Obstructive sleep apnea
(2) Ability to understand instructions for opening and closing, swallowing and tongue protrusion.
(3)No abnormality is found in the oral morphology
(4) Oral feeders
Key exclusion criteria
(1)Abnormalities in oral morphology (cleft palate, edentulism, etc.)
(2) Parenteral feeding (tube feeding)
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Inoshita |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
113
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
ayaent@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Inoshita |
Organization
Juntendo University
Division name
Otorhinolaryngology
Zip code
113-8431
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
ayaent@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Hospital
Address
3-1-3, Hongo, Bunkyo-ku, Tokyo
Tel
03-3813-3111
ayaent@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
18
Results
In pediatric obstructive sleep apnea (OSA), reduced tongue pressure and lateral asymmetry in buccal pressure were observed.
Following adenoidectomy and tonsillectomy, significant improvements in apnea hypopnea index, tongue pressure and buccal pressure were observed compared with preoperative values.
In addition, a significant increase in nasal airflow was observed postoperatively.
Results date posted
| 2026 | Year | 02 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Children aged from 3 to 15 years who were diagnosed with obstructive sleep apnea based on overnight polysomnography.
Participant flow
Patients who were diagnosed with obstructive sleep apnea at Juntendo University Hospital and underwent adenoidectomy and bilateral tonsillectomy.
Adverse events
None
Outcome measures
Apnea hypopnea index, tongue pressure, buccal pressure, nasal airflow
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 08 | Month | 08 | Day |
Last modified on
| 2026 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047216
