UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050311
Receipt number R000057288
Scientific Title Satisfaction with wearing hearing aids-Examination of factors that affect satisfaction-
Date of disclosure of the study information 2023/04/01
Last modified on 2023/08/15 15:50:45

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Basic information

Public title

Satisfaction with wearing hearing aids-Examination of factors that affect satisfaction-

Acronym

Satisfaction with wearing hearing aids-Examination of factors that affect satisfaction-

Scientific Title

Satisfaction with wearing hearing aids-Examination of factors that affect satisfaction-

Scientific Title:Acronym

Satisfaction with wearing hearing aids-Examination of factors that affect satisfaction-

Region

Japan


Condition

Condition

Hearing impairment

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines the degree of satisfaction with wearing hearing aids and the factors that affect the degree of satisfaction.

Basic objectives2

Others

Basic objectives -Others

Effect of the questionnaire method

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

questionnaire method

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Hearing aid users

Key exclusion criteria

Normal Hearing

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kei
Middle name
Last name SAKAMOTO

Organization

saitama medical university hospital

Division name

otorhinolaryngology

Zip code

3500495

Address

38, Morohongo, Iruma Gun Moroyama Machi, Saitama Ken, 350-0451, Japan

TEL

0492761296

Email

sakamoto.kei@1972.saitama-med.ac.jp


Public contact

Name of contact person

1st name Kei
Middle name
Last name SAKAMOTO

Organization

Saitama Medical University

Division name

otorhinolaryngology

Zip code

3500495

Address

38, Morohongo, Iruma Gun Moroyama Machi, Saitama Ken, 350-0451, Japan

TEL

0492761296

Homepage URL


Email

sakamoto.kei@1972.saitama-med.ac.jp


Sponsor or person

Institute

saitama Medical univerisity

Institute

Department

Personal name



Funding Source

Organization

self-procurement

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

saitama medical univercity IRB

Address

38, Morohongo, Iruma Gun Moroyama Machi, Saitama Ken, 350-0451, Japan

Tel

049-276-1111

Email

hirb@saitama-med.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

2023 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

Enrolling by invitation

Date of protocol fixation

2023 Year 02 Month 12 Day

Date of IRB

2023 Year 05 Month 08 Day

Anticipated trial start date

2023 Year 05 Month 08 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry

2026 Year 05 Month 08 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

We will examine the factors that affect the degree of satisfaction with hearing aids based on questionnaires and individual factors.


Management information

Registered date

2023 Year 02 Month 12 Day

Last modified on

2023 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057288


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name