UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010837 |
|---|---|
| Receipt number | R000012690 |
| Scientific Title | The cochlin-tomoprotein detection test: Diagnosis of perilymphatic fistula causing sudden sensorineural hearing loss |
| Date of disclosure of the study information | 2013/05/30 |
| Last modified on | 2023/12/07 21:07:22 |
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Basic information
Public title
The cochlin-tomoprotein detection test: Diagnosis of perilymphatic fistula causing sudden sensorineural hearing loss
Acronym
The cochlin-tomoprotein detection test for sudden sensorineural hearing loss
Scientific Title
The cochlin-tomoprotein detection test: Diagnosis of perilymphatic fistula causing sudden sensorineural hearing loss
Scientific Title:Acronym
The cochlin-tomoprotein detection test for sudden sensorineural hearing loss
Region
| Japan |
Condition
Condition
Sudden sensorineural hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine rate of perilymphatic fistula in sudden sensorineural hearing loss by expression of cochlin-tomoprotein
Basic objectives2
Others
Basic objectives -Others
The causes of most sudden sensorineural hearing loss have been unclear, and so treatment for this disease has not been established.
Perilymphatic fistula (PLF) is defined as abnormal connections between the fluid (perilymph)-filled space of the inner ear and the air-filled space of the middle ear. The primary manifestations of perilymph fistulization are sudden or progressive fluctuating sensorineural hearing loss and vertigo. However, the symptoms are not characteristic, especially in cases that have no history of trauma, thus PLF might be confused with idiopathic sudden sensorineural hearing loss. Ikezono et al. have previously found cochlin-tomoprotein (CTP), a protein that might be specific to the perilymph.
The purpose of this study was the determination of the rate of perilymphatic fistula in idiopathic sudden sensorineural hearing loss by detection of cochlin-tomoprotein of middle ear lavage.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of detection of cochlin-tomoprotein of middle ear lavage in subjects with sudden sensorineural hearing loss
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects were patients who were diagnosed with definite or probable idiopathic sudden sensorineural hearing loss (according to the criteria set by the Sudden Deafness Research Committee of the Japanese Ministry of Health, Labour and Welfare in 1973). Subjects also satisfied the following conditions; (1) sensorineural hearing loss that clearly took place within 72 hours, (2) pure tone average at five frequencies (250, 500, 1000, 2000 and 4000 Hz) ranged 40 dB or more, (3) diagnosis within 28 days after the onset, (4) able to come to the outpatient clinic.
Key exclusion criteria
The exclusion criteria were as follows; (1) acoustic neurinoma or other CNS disorder causing hearing loss by MRI scan, (2) viral labyrinthitis by clinical symptoms and increase of antibody titer, (3) sensorineural hearing loss occurring after administration of aminoglycosides, loop diuretics or platinum-based drugs, (4) sensorineural hearing loss occurring following exposure to loud noise, (5) perilymphatic fistula caused from trauma, cholesteatoma, tumor of the middle ear, malformation of the inner or middle ear or surgery in the inner or middle ear, (6) chronic otitis media, acute otitis media, otitis media with effusion, traumatic perforation, bleeding or redness of the tympanic membrane, (7) severe systemic illness with a short life expectancy such as malignant tumors, (8) pregnancy or lactation, (9) diagnosis as inappropriate for the trial.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Sasaki |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
036-8562
Address
5 Zaifu, Hirosaki, Aomori 036-8562, JAPAN
TEL
0172-39-5099
akiras@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Sasaki |
Organization
Hirosaki University Graduate School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
036-8562
Address
5 Zaifu, Hirosaki, Aomori 036-8562, JAPAN
TEL
0172-39-5099
Homepage URL
orl@hirosaki-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology, Hirosaki University
Institute
Department
Personal name
Akira Sasaki
Funding Source
Organization
Department of Otorhinolaryngology, Saitama Medical University
Tetsuo Ikezono
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Otolaryngology, Saitama Medical University
Tetsuo Ikezono
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hirosaki University Graduate School of Medicine
Address
5 Zaifu, Hirosaki, Aomori 036-8562, JAPAN
Tel
0172-33-5111
akiras@hirosaki-u.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
| 2013 | Year | 05 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2013 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2013 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective Study
Management information
Registered date
| 2013 | Year | 05 | Month | 29 | Day |
Last modified on
| 2023 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012690
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