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Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss

ConditionSudden Hearing Loss
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-75
SponsorEye & ENT Hospital of Fudan University

About this trial

Safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with profound or complete sudden sensorineural hearing loss

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 12 and 75 years Unilateral idiopathic sudden sensorineural hearing loss diagnosed by Pure tone test, CT and MRI Symptoms of sudden deafness occur within ≥ 7 days and, after conventional treatment, the average thresholds at 500 Hz, 1000 Hz, 2000 Hz and 4000 Hz are ≥ 80 dBHL

Disqualifiers

Bilateral sudden sensorineural hearing loss Hearing loss with known causes (e.g., Meniere's disease, retrocochlear pathology, history of otologic surgery, perilymphatic fistula, barotrauma) History in the past 6 months of ototoxic treatment such as chemotherapy, use of loop diuretics, high dose aspirin, etc.

Trial design

Design model

Parallel

Treatments tested in this trial

  • intracochlear injection of triamcinolone acetonide through the round window membrane

    Drug

    intracochlear injection of triamcinolone acetonide through the round window membrane

  • intratympanic dexamethasone injection through the tympanic membrane

    Drug

    intratympanic dexamethasone injection through the tympanic membrane

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Group 1：intracochlear dexamethasone injectionExperimental treatment 1 intervention
Group B: Group 2: intratympanic dexamethasone injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in pure tone audiometry (PTA)

hearing capacity of thresholds ( PTA)

Time frame
Baseline , Week2 , Week4, Week12, Week24.
2

Change from Baseline in Speech Discrimination Scores

hearing capacity of thresholds ( speech discrimination )

Time frame
Baseline , Week4, Week12, Week24.

Secondary outcomes

1

Change from Baseline in auditory brainstem re-sponse (ABR)

hearing capacity of thresholds ( ABR)

Time frame
Baseline, Week12
2

Change from Baseline in auditory steady-state response (ASSR)

hearing capacity of thresholds (ASSR)

Time frame
Baseline, Week12
3

change from baseline in tinnitus handicap inventory

The scales assess changes in tinnitus

Time frame
Baseline, Week2, Week4, Week12, Week24
4

change from baseline in dizziness handicap inventory

The scales assess changes in vertigo

Time frame
Baseline, Week2, Week4, Week12, Week24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye & ENT Hospital of Fudan University

Lead sponsor

Shanghai Zhongshan Hospital

Collaborator

Shenzhen Second People's Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: