UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056936 |
|---|---|
| Receipt number | R000065067 |
| Scientific Title | Exploratory study on sound localization performance under cognitive load in normal-hearing subjects and patients with listening difficulties |
| Date of disclosure of the study information | 2025/02/20 |
| Last modified on | 2025/02/04 23:36:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory study on sound localization performance under cognitive load in normal-hearing subjects and patients with listening difficulties
Acronym
Exploratory study on sound localization performance under cognitive load in normal-hearing subjects and patients with listening difficulties
Scientific Title
Exploratory study on sound localization performance under cognitive load in normal-hearing subjects and patients with listening difficulties
Scientific Title:Acronym
Exploratory study on sound localization performance under cognitive load in normal-hearing subjects and patients with listening difficulties
Region
| Japan |
Condition
Condition
Listening difficulties
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The ability to localize sound sources under conditions of attentional interference, shortened stimulus duration, and reduced sound pressure levels was explored in normal hearing subjects and patients with listening difficulties, and a clinical test method for sound source localization in patients with listening difficulties was developed in order to provide basic data for the establishment of a clinical test method for sound source localization ability in patients with h
Basic objectives2
Others
Basic objectives -Others
exploratory observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of correct responses to sound source localization answers.
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
| 18 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy hearing subjects (normal volunteers)
1 Normal hearing subjects with no abnormalities in auditory function with no history of ear or nerve/neurological diseases
2 Age: 18 years old or older, less than 50 years old (at the time of registration)
3 Gender: Any gender
(2) Listening difficulties patients (patient volunteers)
1 Patients diagnosed with the syndrome or suspected to have the syndrome by an audiologic examination at an ENT clinic.
2 Age: 18 years old or older, under 50 years old (at the time of registration)
3 Gender: Any gender
Key exclusion criteria
(1) Healthy hearing subjects (normal volunteers)
1) Subjects with a history of ear disease
2. History of psychiatric disorders
3. History of peripheral or central nervous system disease
4 Pregnancy or possible pregnancy
5 Other patients who are judged to be inappropriate as subjects by the Principal Investigator or a Research Associate.
(2) Patients with Lstening difficulties (patient volunteers)
1 Patients with a history of peripheral or central nervous system disease
2 Those who are pregnant or may become pregnant
3 Other patients who are judged to be unsuitable as subjects by the principal investigator or a research associate.
(#Listening difficulties are known to be caused by a history of childhood ear diseases, neurodevelopmental disorders, depression and other psychiatric disorders.
(Since it is known that patients with #Listening difficulties also have a history of childhood ear disorders, neurodevelopmental disorders, and psychiatric disorders such as depression, we did not add the conditions of a history of ear disorders or psychiatric disorders to the exclusion criteria for patients with normal hearing.)
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Katori |
Organization
Tohoku University
Division name
Otolaryngology-Head and Neck surgery
Zip code
980-8574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai City
TEL
0227177304
yukio.katori.d1@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Otolaryngology-Head and Neck surgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
0227177304
Homepage URL
tetsuaki.kawase.e8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
the Ministry of Education, Culture, Sports, Science and Technology-Japan
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
Tohoku University Graduate School of Medicine Ethics Committee
Address
2-1 Seiryo-machi, Aoba-ku, Sendai
Tel
0227178007
med-kenkyo@grp.tohoku.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
| 2025 | Year | 02 | Month | 20 | 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
| 2025 | Year | 01 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study on the evaluation of sound localization ability in normal subjects and a group of patients (patients with listening difficulties)
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065067
