UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035189
Receipt number 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 2020/06/17 00:40:17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Yumi
Middle name
Last name Ohta

Organization

Osaka University

Division name

Otorhinolaryngology and Head and Neck Surgery

Zip code

5650871

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 Yumi
Middle name
Last name Ohta

Organization

Osaka University

Division name

Otorhinolaryngology and Head and Neck Surgery

Zip code

5650871

Address

2-2 Yamadaoka Suita, Osaka

TEL

06-6879-3951

Homepage URL


Email

yota@ent.med.osaia-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



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

Academic Clinical Research Center of Osaka University Hospital

Address

2-2 Yamadaoka Suita, Osaka

Tel

06-6210-8289

Email

rinri@hp-crc.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



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

Completed

Date of protocol fixation

2013 Year 06 Month 13 Day

Date of IRB

2013 Year 06 Month 13 Day

Anticipated trial start date

2013 Year 06 Month 13 Day

Last follow-up date

2019 Year 01 Month 19 Day

Date of closure to data entry

2019 Year 01 Month 19 Day

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

2020 Year 06 Month 17 Day



Link to view the page

Value
https://center6.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