The cochlin-tomoprotein detection test: Diagnosis of perilymphatic fistula causing sudden sensorineural hearing loss

The cochlin-tomoprotein detection test: Diagnosis of perilymphatic fistula causing sudden sensorineural hearing loss - The cochlin-tomoprotein detection test for sudden sensorineural hearing loss

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000010837

Enrollment

Registered

2013-05-30

Start date

2013-05-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden sensorineural hearing loss

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
The rate of detection of cochlin-tomoprotein of middle ear lavage in subjects with sudden sensorineural hearing loss	—

Countries

Japan

Contacts

Public ContactAkira Sasaki

Hirosaki University Graduate School of Medicine Department of Otorhinolaryngology

orl@hirosaki-u.ac.jp0172-39-5099

Outcome results