UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048529 |
|---|---|
| Receipt number | R000055294 |
| Scientific Title | Exploratory study on the evaluation of sound saliency using pupil diameter as an indicator and its potential clinical application |
| Date of disclosure of the study information | 2022/08/01 |
| Last modified on | 2024/03/01 23:02:15 |
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Basic information
Public title
Exploratory study on the evaluation of sound saliency using pupil diameter as an indicator and its potential clinical application
Acronym
Exploratory study on the evaluation of sound saliency using pupil diameter as an indicator
Scientific Title
Exploratory study on the evaluation of sound saliency using pupil diameter as an indicator and its potential clinical application
Scientific Title:Acronym
Exploratory study on the evaluation of sound saliency using pupil diameter as an indicator
Region
| Japan |
Condition
Condition
Tinnitus, Hyperacusis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
After establishing an evaluation method using pupil diameter for sound "saliency" (i.e., attractiveness of sound) in volunteers with normal hearing and evaluating its characteristics, we will optimize the test conditions for clinical use, which are appropriate for investigating whether or not there is pathology in the evaluation of sound "saliency" in patients with severe tinnitus (volunteers) and patients with acoustic hypersensitivity (volunteers), as well as whether or not there are changes accompanying improvement of symptoms.
Basic objectives2
Others
Basic objectives -Others
pathophysiological elucidation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pupil diameter
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
| 15 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(A) Healthy hearing subjects
(1) Healthy hearing subjects with no history of ear disease or neurological/neurological disease
2) Age: 20 years old or older, less than 40 years old (at the time of registration)
(3) Gender: Any gender
(B) Tinnitus patients
(1) Patients with a tinnitus severity score (Tinnitus Handicap Inventory: THI) of 40 points or higher
(THI is a tinnitus severity questionnaire routinely administered in the outpatient clinic (maximum score 100 points); a score of 40 or more is considered to indicate moderate or severe tinnitus requiring some form of therapeutic intervention.)
(2) Age: 20 years old or older, less than 40 years old
(3) Gender: Any gender.
(C) Hyperacusis patients
(1) Patients with a hearing sensitivity score (Hyperacusis Questionaire: HQ) of 28 points or higher
(HQ is a questionnaire on the degree of distress of auditory sensitivity that is routinely administered in the outpatient clinic (maximum score 42 points). 28 points or more is considered as having a strong auditory sensitivity that requires some therapeutic intervention.)
(2) Age: 20 years old or older, less than 40 years old
(iii) Gender: Any gender.
Key exclusion criteria
(A) Hearing subjects
1) Those with a history of ear disease
2) Those with a history of mental illness
3) Those with a history of peripheral or central nervous system diseases
4) Those with a history of eye diseases (excluding myopia)
5) Those who are taking drugs that may affect the pupil system (antihistamines, decongestants, antidepressants, anti-vomiting agents, anticonvulsants, Parkinson drugs, etc.)
6) Those who are pregnant or may become pregnant
7) In addition, those who are judged by the principal investigator or coordinator to be inappropriate as subjects
(B) Tinnitus patients, hyperacusis patients
1) Those with a history of eye diseases (excluding myopia)
2) Those who are taking drugs that may affect the pupil system (antihistamines, decongestants, antidepressants, anti-vomiting agents, anticonvulsants, Parkinson drugs, etc.)
3) Those who are pregnant or may become pregnant
4) In addition, those who are judged by the principal investigator or coordinator to be inappropriate as subjects
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-7303
kawase@orl.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Senda
TEL
022-717-7303
Homepage URL
kawase@orl.med.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
| 2022 | Year | 08 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing particular
Management information
Registered date
| 2022 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055294
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