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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035189
Receipt No. R000040110
Scientific Title The influence of ear surgery for elderly patients on their cognitive function, morale and sociality
Date of disclosure of the study information 2019/12/09
Last modified on 2018/12/09

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Basic information
Public title The influence of ear surgery for elderly patients on their cognitive function, morale and sociality
Acronym The influence of ear surgery for elderly patients on their cognitive function, morale and sociality
Scientific Title The influence of ear surgery for elderly patients on their cognitive function, morale and sociality
Scientific Title:Acronym The influence of ear surgery for elderly patients on their cognitive function, morale and sociality
Region
Japan

Condition
Condition Hearing impairment (Chronic otitis media, cholesteatoma, tympanosclerosis, otosclerosis, severe sensorineural hearing impairment)
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Hearing impairment causes deterioration of sociality and it is considered that hearing impairment influence the cognitive function. This study aims to evaluate how ear surgery for elderly patients influence their cognitive function, morale and sociality.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cognitive function (1 year, 2 years after surgery)
Key secondary outcomes QOL of hearing, depression score

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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who will be performed ear surgery which aims to improve hearing level such as tympanoplasty, stapes surgery, cochlear implantation or implantation of BAHA.
Key exclusion criteria Patients with severe dementia (impossible to examine hearing level)
Aim of the surgery is not improvement of hearing.
Impossible to follow up after surgery
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yumi Ohta
Organization Osaka University
Division name Otorhinolaryngology and Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka Suita, Osaka
TEL 06-6879-3951
Email yota@ent.med.osaia-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yumi Ohta
Organization Osaka University
Division name Otorhinolaryngology and Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka Suita, Osaka
TEL 06-6879-3951
Homepage URL
Email yota@ent.med.osaia-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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
2019 Year 12 Month 09 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
2013 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To evaluate cognitive function, apathy and depression by questionnaire before and after the ear surgery

Management information
Registered date
2018 Year 12 Month 09 Day
Last modified on
2018 Year 12 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040110

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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