UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054022 |
|---|---|
| Receipt number | R000059500 |
| Scientific Title | Exploring neurodevelopmental disorders and psychosocial factors in childhood functional hearing loss |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/10/16 15:00:26 |
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Basic information
Public title
Exploring neurodevelopmental disorders and psychosocial factors in childhood functional hearing loss
Acronym
Exploring neurodevelopmental disorders and psychosocial factors in childhood functional hearing loss
Scientific Title
Exploring neurodevelopmental disorders and psychosocial factors in childhood functional hearing loss
Scientific Title:Acronym
Exploring neurodevelopmental disorders and psychosocial factors in childhood functional hearing loss
Region
| Japan |
Condition
Condition
Childhood functional hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will assess the developmental characteristics of children with functional hearing loss and their caregivers, investigate stressors that may contribute to functional hearing loss, and examine the relationship between childhood functional hearing loss and developmental disorders. We will also interview children about their support needs related to functional hearing loss and conduct a prognostic survey regarding symptom outcomes to explore potential support and treatment.
Basic objectives2
Others
Basic objectives -Others
Explore associated factors in childhood functional hearing loss
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of neurodevelopmental disorders in childhood functional hearing loss
Key secondary outcomes
Cognitive function, developmental disorder characteristics, adverse childhood experiences, parental attitude toward children, support needs, symptom outcome, QoL. Symptoms, support needs, and QoL 6 to 12 months after the initial assessment.
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
| 6 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Caregivers and children between 6 and 18 years old diagnosed with functional hearing loss who have given their consent to participate in the study
Key exclusion criteria
Children having been diagnosed with an intellectual disability, and for whom its problems affect their daily life, and who are already receiving supports for those problems (such as special needs education, medical care, etc.)
Children or caregivers who are determined by the attending physician to be inappropriate for inclusion due to serious psychological trauma or child abuse, or are at high risk of mental insatabilities.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka University
Division name
Graduate School of Human Sciences
Zip code
5650871
Address
1-2, Yamadaoka, Suita, Osaka
TEL
06-6879-8095
mmatsu.hus@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Matsumoto |
Organization
Osaka University
Division name
Graduate School of Human Sciences
Zip code
565-0871
Address
1-2, Yamadaoka, Suita, Osaka
TEL
06-6879-8095
Homepage URL
mmatsu.hus@osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Megumi Matsumoto
Funding Source
Organization
MEXT(Japan), Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Osaka University Hospital
Address
2-2, Yamadaoka, Suita, Osaka
Tel
06-6210-8289
rinri@hp-crc.med.osaka-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
大阪大学医学部附属病院（大阪府）、市立池田病院（大阪府）、大阪大学大学院人間科学研究科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational cohort study
Management information
Registered date
| 2024 | Year | 04 | Month | 01 | Day |
Last modified on
| 2024 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059500
