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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028241
Receipt No. 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 2017/09/15

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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
Email 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
Email aoki@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
Email

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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
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
2017 Year 09 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032318

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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