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
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
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
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
