UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038792 |
|---|---|
| Receipt number | R000044228 |
| Scientific Title | The effect of hearing aids on posturography in the elderly |
| Date of disclosure of the study information | 2020/01/07 |
| Last modified on | 2022/06/06 16:43:49 |
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Basic information
Public title
The effect of hearing aids on posturography in the elderly
Acronym
Hearing aids and posturography in the elderly
Scientific Title
The effect of hearing aids on posturography in the elderly
Scientific Title:Acronym
Hearing aids and posturography in the elderly
Region
| Japan |
Condition
Condition
sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the effect of hearing aids on the posturography in the elderly
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
total length, area, velocity, center of foot pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
sensorineural heairng loss
Interventions/Control_2
normal hearing
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those with bilateral sensorineural hearing loss attendind Iwate Medical Univeristy
Those older than 60, without other neuromuscular diseases
Those who are wearing a hearing aid more than 1 year
Key exclusion criteria
Those who cannot stand still during the examination
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Harukazu |
| Middle name | |
| Last name | Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology
Zip code
028-3695
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
019-613-7111
hhiraumi@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Harukazu |
| Middle name | |
| Last name | Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology
Zip code
028-3695
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate, Japan
TEL
019-613-7111
Homepage URL
hhiraumi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Iwate Medical University
Address
2-1-1, Idai doori, Yahaba City, Shiwa, Iwate
Tel
019-613-7111
hhiraumi@iwate-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
岩手医科大学、岩手県立大学
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258590
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0258590
Number of participants that the trial has enrolled
20
Results
The interaction among eye condition, sound condition, and between-group factor was significant in the maximum displacement of the center-of-pressure in the mediolateral axis. The maximum displacement of the center-of-pressure in the mediolateral axis improved with the auditory cues in the normal-hearing participants in the eyes closed condition. In the hearing aid users, this difference was not significant.
Results date posted
| 2022 | Year | 06 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We recorded the findings of 10 experienced hearing aid users and 10 normal-hearing participants
Participant flow
Recruited at Iwate Medical University
Adverse events
No
Outcome measures
The posturographic measurements were conducted under eight conditions: (1) eyes open on a foam pad, with and without HA, (2) eyes closed on a foam pad, with and without HA, (3) eyes open on a rigid surface, with and without HA, and (4) eyes closed on a rigid surface, with and without HA.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 23 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2021 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2021 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 04 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044228
