UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010837
Receipt No. 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 2016/11/25

* 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 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
Middle name
Last name Akira Sasaki
Organization Hirosaki University Graduate School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 5 Zaifu, Hirosaki, Aomori 036-8562, JAPAN
TEL 0172-39-5099
Email akiras@hirosaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Sasaki
Organization Hirosaki University Graduate School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 5 Zaifu, Hirosaki, Aomori 036-8562, JAPAN
TEL 0172-39-5099
Homepage URL
Email orl@hirosaki-u.ac.jp

Sponsor
Institute Department of Otorhinolaryngology, Hirosaki University
Institute
Department

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
Address
Tel
Email

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 Open public recruiting
Date of protocol fixation
2013 Year 01 Month 08 Day
Date of IRB
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
2016 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012690

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.