UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023214 |
|---|---|
| Receipt number | R000026648 |
| Scientific Title | Effects of the auditory space on balance in cochlear implantation patients |
| Date of disclosure of the study information | 2016/09/10 |
| Last modified on | 2024/04/26 09:47:22 |
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Basic information
Public title
Effects of the auditory space on balance in cochlear implantation patients
Acronym
CI and balance
Scientific Title
Effects of the auditory space on balance in cochlear implantation patients
Scientific Title:Acronym
CI and balance
Region
| Japan |
Condition
Condition
Cochlear implantation recipients
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the auditory space recognition on balance function in cochlear implant patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To see the effect of CI activation on the postulography in various sound condition and various CI condition.
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
| 4 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
CI recipients attending Iwate Medical University
Key exclusion criteria
Those who cannot tolerate the postulography
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, Head and Neck Surgery
Zip code
028-3694
Address
19-1, Uchimaru, Morioka
TEL
019-651-5111
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, Head and Neck Surgery
Zip code
028-3694
Address
19-1, Uchimaru, Morioka
TEL
019-651-5111
Homepage URL
hhiraumi@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Iwate Medical University
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
iwate medical university
Address
19-1, Uchimaru, Morioka
Tel
019-651-5111
kenkyu-rinri@j.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.clinicalkey.jp/#!/content/playContent/1-s2.0-S1388245718311799?returnurl=https:%2F%2Flin
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/?term=oikawa+k%2C+hiraumi+h
Number of participants that the trial has enrolled
16
Results
In CI subjects, sound stimulation improves the abnormal displacement of COP in the mediolateral direction.
Results date posted
| 2024 | Year | 04 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We evaluated 8 hearing-loss patients with CI on one side. They were recruited at Iwate Medical University (4 males, 4 females; aged between 20 and 61 years, mean 44.0 years). All the subjects had been using CI for more than 3 years (3-21 years, mean 10.4 years). The hearing threshold with CI is 23-33 dBHL (mean 29.4 dBHL). Eight young normal-hearing paid volunteers (3 males, 5 females; aged between 20 and 24 years, mean 21.5 years) with no history of neurological or muscular diseases and who showed normal hearing threshold were recruited as controls..
Participant flow
All of the subjects gave written informed consent, and the study protocol was approved by the Ethics Committee of Iwate Medical University (H28-78) and Iwate Prefectural University (183), in accordance with the Declaration of Helsinki.
Adverse events
None
Outcome measures
All subjects were assessed using posturography (GP-5000, Anima Co., Ltd., Tokyo, Japan) in an anechoic room. All subjects were required to stand on a flat platform with the feet close together for 60 s. The medial surface of the toes and the calcanei were aligned to the center line of the platform. The CI recipients wore their CI during the experiment. The force transducers embedded in the platform continuously measured the displacement of the center of foot pressure (COP) with a sampling frequency of 20 Hz.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 30 | Day |
Other
Other related information
To explore the body balance function by using a postulography in cochlear implant recipients in a normal room and an anechoic room
Management information
Registered date
| 2016 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026648
