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Name
UMIN ID

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000048529
Receipt No. 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 2022/07/31

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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
Email 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
Email kawase@orl.med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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 Open public recruiting
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
2022 Year 07 Month 31 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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