UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055503 |
|---|---|
| Receipt number | R000063423 |
| Scientific Title | Measuring objective auditory temporal resolution using gap auditory steady state response (gASSR) in unilateral hearing loss |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/09/14 16:24:38 |
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Basic information
Public title
Auditory steady state responses in unilateral hearing loss
Acronym
Auditory steady state responses in unilateral hearing loss
Scientific Title
Measuring objective auditory temporal resolution using gap auditory steady state response (gASSR) in unilateral hearing loss
Scientific Title:Acronym
Gap auditory steady state response (gASSR) in unilateral hearing loss
Region
| Japan |
Condition
Condition
unilateral hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is known that handicap and quality of life are reduced in patients with unilateral hearing loss due to difficulty in hearing in noise and reduced localization performance. Auditory temporal resolution, as well as hearing threshold, plays an important role in speech recognition. Objective measurement of changes in brain activity related to auditory temporal resolution in patients with unilateral hearing loss using electroencephalography.
Basic objectives2
Others
Basic objectives -Others
Auditory temporal resolution is measured using gap auditory steady-state response (gASSR) in patients with unilateral hearing loss.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gap auditory steady-state response (gASSR)
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with unilateral moderate hearing loss
Key exclusion criteria
History of psychiatric or neurological disease, cardiac pacemaker, neuro pacemaker, previous head surgery, pregnant, wearing orthodontic appliances
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | hidehiko |
| Middle name | |
| Last name | okamoto |
Organization
International University of Health and Welfare
Division name
School of Medicine
Zip code
286-0048
Address
4-3 Kozunomori, Narita,Chiba Prefecture
TEL
0476-20-7701
okamoto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | nao |
| Middle name | |
| Last name | nojiri |
Organization
International University of Health and Welfare
Division name
Department of Otolaryngology,International University of Health and Welfare Narita Hospital
Zip code
286-8520
Address
852 Hatakeda Narita, Chiba Prefecture
TEL
0476-35-5600
Homepage URL
nao-nojiri@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare
Address
4-3 Kozunomori, Narita,Chiba Prefecture
Tel
0476-20-7701
nao-nojiri@iuhw.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
| 2024 | Year | 09 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 24 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objective measurement of changes in brain activity in response to sound stimulation in patients with unilateral hearing loss using electroencephalography (EEG) Patients meeting the criteria who visited our institution between April 2024 and March 2029 will be included.
Management information
Registered date
| 2024 | Year | 09 | Month | 14 | Day |
Last modified on
| 2024 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063423
