UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021716 |
|---|---|
| Receipt number | R000025052 |
| Scientific Title | Neural and mental developments and efficacy of treatments in pediatric sleep apnea syndrome |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2023/04/06 11:43:47 |
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Basic information
Public title
Neural and mental developments and efficacy of treatments in pediatric sleep apnea syndrome
Acronym
Neural and mental developments in pediatric SAS
Scientific Title
Neural and mental developments and efficacy of treatments in pediatric sleep apnea syndrome
Scientific Title:Acronym
Neural and mental developments in pediatric SAS
Region
| Japan |
Condition
Condition
pediatric sleep apnea syndrome
Classification by specialty
| Pediatrics | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
degree of development and improvement after the operation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neural and mental developments
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
quenstionnaire
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients for PSG
Key exclusion criteria
None
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Komori |
Organization
Kochi University, School of Medicine
Division name
Department of Otolaryngology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku
TEL
088-880-2393
komori@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Komori |
Organization
Kochi University, School of Medicine
Division name
Department of Otolaryngology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nankoku
TEL
088-880-2393
Homepage URL
komori@kochi-u.ac.jp
Sponsor or person
Institute
Department of Otolaryngology, Kochi University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Kochi medical school
Address
Kohasu, Oko, Nankoku
Tel
088-866-5811
komori@kochi-u.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
| 2016 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective time-series study;
All patients presenting with sleep apnea were included to investigate the relationship between severity of apnea and neural and mental developments, and improvement after surgery using questionnaire
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2023 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025052
