Safety and Efficacy of Intratympanic Application of Dexamethasone Via Catheter in Patients With Sudden Hearing Loss

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Completed

CT.gov ID

NCT00335920

Collaborator

(none)

Enrollment

Locations

Duration (Months)

7.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of an intratympanic continuous two-week application of dexamethasone compared to placebo using a temporarily implanted catheter in patients with severe to profound sudden sensorineural hearing loss and insufficient recovery after initial systemic prednisolone therapy.

Condition or Disease	Intervention/Treatment	Phase
Sudden Deafness	Drug: Dexamethasone-dihydrogenphosphate (4mg/ml)	Phase 3

Detailed Description

Patients suffering from unilateral severe to profound sudden sensorineural hearing loss (ISSNHL) or anacusis with no or insufficient recovery after 12-21 days after onset will be treated for 14 days with Dexamethasone or placebo delivered intratympanically via a micro-catheter temporarily implanted into the round window niche and an external mini-pump.

Due to the relatively unknown risks of intratympanic treatment by catheter implantation, a significant spontaneous recovery rate and an existing standard therapy for ISSNHL in Germany (systemic glucocorticoids), patients will only be enrolled into the study if no or insufficient recovery of hearing threshold could be observed after initial systemic therapy.

The study will be carried out until 10 patients per group have been randomized regardless in which study center they have been randomized. After the last patient of these 10 patients per group has reached the endpoint an interim analysis will be done. The statistical estimation of the total number of subjects to be randomized will be completed after this interim analysis by the responsible statistician.

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Prospective, Randomized, Double Blind, Placebo Controlled, Multicenter Study on the Safety and Efficacy of Continuous Infusion of Corticosteroid Delivered Via Catheter in Patients With Idiopathic Sudden Sensorineural Hearing Loss

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 1, 2007

Outcome Measures

Primary Outcome Measures

Pure tone audiometric threshold []

Secondary Outcome Measures

Word recognition (speech audiometry) []
tinnitus improvement []
adverse events (worsening of hearing and/or vertigo and/or tinnitus, middle ear inflammation, pain) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signed informed consent form
Age is greater than 18 years old and less than 75 years old.
Diagnosis of unilateral Idiopathic sudden sensorineural hearing loss (i.e. sudden sensorineural hearing loss of unknown etiology
Sensorineural hearing loss is at least 50 dB or more for three or more frequencies in standard pure tone, bone-conducted audiogram within the range of 500 Hz to 4000 Hz (500, 1000, 2000, 3000 and 4000), 60 dB or more for two of these frequencies or 70 dB or more for any frequency within this range, or a decrease in the SRT to 70 dB or greater (not accounted for by conductive hearing loss) or a drop in speech discrimination score to less than or equal to 30%
hearing loss occurred within 72 hours
Hearing loss occurred at least 12 days ago but less than or equal to 21 days ago
Insufficient recovery of the ISSNHL at least 12 days after onset whether or not the patient received Local Standard Therapy (i.e. Hearing in the contralateral ear is at least 20 dB better than the affected ear in at least three frequencies (any three of 500, 1000, 2000, 3000, 4000 Hz))

Exclusion Criteria:

Age is less than 18 or greater than 75 years old
Hearing loss occurred less than 12 days or more than 21 days ago
Positive pregnancy test, risk of pregnancy (insufficient protection or lactation
Middle ear inflammation or effusion
Ear canal inflammation
Conductive hearing loss of greater than 10 dB
Sudden bilateral hearing loss
Presence of any conditions or symptoms which indicate that the hearing loss is not ISSNHL, for example, acoustic trauma, Meniere's disease, fluctuating hearing loss, endolymphatic hydrops, suspected retro-cochlear lesion, hearing loss due to ear surgery, perilymph fistula or barotrauma.
Pulse synchronic tinnitus (potentially due to glomus jugulare tumor)
Previous otologic surgery (excluding ventilation tubes)
History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.
Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
Use of non-permitted treatment during the study
Intake of experimental drugs or participation in a clinical study within the last 30 days
Only hearing ear
History of drug abuse or alcoholism
History of an ischemic disorder (previous strokes, previous heart attacks, peripheral arterial occlusion disease)
Patient is not capable of understanding the informed consent form (whether due to its language or for other reasons)
Any psychiatric syndrome requiring treatment with neuroleptics, antidepressants, hypnotics or anxiolytics which has/have been prescribed within three month preceding inclusion into the study and/or cannot be continued at the same dose during the study
Any severe (systemic) neurological disease (e.g. Epilepsy, Parkinson's disease, Dementia/Alzheimer's disease, Multiple sclerosis)
Any reason, in the investigator's opinion, that prohibits inclusion into the study

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	St. Vincentius Kliniken, Klinik für HNO Heilkunde	Karlsruhe	Germany	76042
2	Department of Otorhinolaryngology, University of Tubingen	Tubingen	Germany	72076
3	Bundeswehrkrankenhaus Ulm	Ulm	Germany	89081

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator: Hans-Peter Zenner, M.D., Department of Otorhinolaryngology, University of Tubingen
Study Director: Stefan K Plontke, M.D., Department of Otorhinolaryngology, University of Tubingen