UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028241 |
|---|---|
| Receipt number | R000032318 |
| Scientific Title | Involvement of brain volume and stress-related hormone in cognitive impairment with age-related hearing loss |
| Date of disclosure of the study information | 2017/08/01 |
| Last modified on | 2020/05/04 11:31:35 |
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Basic information
Public title
Involvement of brain volume and stress-related hormone in cognitive impairment with age-related hearing loss
Acronym
Association between stress-related hormone and cognitive impairment with age-related hearing loss
Scientific Title
Involvement of brain volume and stress-related hormone in cognitive impairment with age-related hearing loss
Scientific Title:Acronym
Association between stress-related hormone and cognitive impairment with age-related hearing loss
Region
| Japan |
Condition
Condition
age-related hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate association of arteriosclerosis, oxidative stress, HHPA axis related-hormone with brain structual change related with speech discrimintion dysfuncton
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
brain volume of extraauditory pathway bu MRIT1
Key secondary outcomes
speech discrimination, hearing level, HDSR, GDS, HHIE and blood findings (CRP, IL6, IL1b, TNFa, HDLC, LDLC, oxidative LDL, DHEAS, Cortisol, HbA1c, adiponectine)
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 patients visiting in Gifu University Hospital, Department of Otolaryngology
2 patients aged more than 60 years olds
3 patients with mild hearingl loss of more than 25dB
Key exclusion criteria
1) patients with ear drum perforation, secretion in middle ear
2) patients with congenital heraing loss
3) persons who have pace maker, cchlear implant, or other metal compatible with a contrindication of MRI
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Aoki |
Organization
Gifu University Hospital
Division name
Department of Biomedical Informatics
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-232-6279
aoki@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Aoki |
Organization
Gifu University Hospital
Division name
Department of Biomedical Informatics
Zip code
Address
1-1 Yanagido, Gifu city
TEL
058-230-7292
Homepage URL
aoki@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
japan society for promotion of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
GDS, HDSR,HHIE, hearing test, blood finding test, MRI, hearing tests
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2020 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032318
