Health TrialsbyHealthPanel

Intracochlear Injection of Glucocorticoid

ConditionSudden Sensorineural Hearing Loss (SSNHL)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEye & ENT Hospital of Fudan University

About this trial

This study is a prospective, randomized pilot study. To verify safety and efficacy of intracochlear injection of glucocorticoid through the round window membrane in patients with total sudden sensorineural hearing loss safety and efficacy in total sudden sensorineural hearing loss patients as an early salvage therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • intracochlear triamcinolone acetonide injection

    Drug

    intracochlear triamcinolone acetonide injection of through the round window membrane

  • intracochlear injection of dexamethasone through the round window membrane

    Drug

    intracochlear injection of dexamethasone sodium phosphate through the round window membrane

  • intracochlear dexamethasone injection and intratympanic dexamethasone injection

    Drug

    intracochlear dexamethasone sodium phosphate injection of through the round window membrane, intratympanic dexamethasone sodium phosphate injection through the tympanic membrane

  • intratympanic dexamethasone injection

    Drug

    intratympanic dexamethasone sodium phosphate injection (10mg/ml) through tympanic membrane，once every other day, for a total of 4 injections.

Treatment groups

150 Participants
are divided into 4 treatment groups
Group A: Group A: intracochlear triamcinolone acetonide injectionExperimental treatment 1 intervention
Group B: Group B: intracochlear dexamethasone injectionExperimental treatment 1 intervention
Group C: Group C: intracochlear dexamethasone injection and intratympanic dexamethasone injectionExperimental treatment 1 intervention
Group D: Group D: 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, Week 2, Week 4, Week12, Week24
2

Change from Baseline in auditory brainstem response (ABR)

hearing capacity of thresholds (ABR)

Time frame
Baseline, Week 2, Week 4, Week12, Week24
3

Change from Baseline in auditory steady state response (ASSR)

hearing capacity of thresholds (ASSR)

Time frame
Baseline, Week 2, Week 4, Week12, Week24
4

Change from Baseline in speech Discrimination Scores

hearing capacity of thresholds (speech Discrimination Scores)

Time frame
Baseline, Week 2, Week 4, Week12, Week24

Secondary outcomes

1

change from baseline in tinnitus handicap inventory

The THI questionnaire includes functional, emotional, and catastrophic subscales. It consists of 25 questions. The total score is calculated by adding up the scores for all questions and classifying the severity of tinnitus as no handicap (0-16), mild handicap (18-36), moderate handicap (38-56), and severe handicap (58-100).

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

change from baseline in dizziness handicap inventory

The 25-item self-report Dizziness Handicap inventory (DHI) validated questionnaire that assesses functional, emotional and physical domains. Responses are graded 0 (no), 2 (sometimes) or 4 (yes) with higher scores indicating greater impact of dizziness maximum and maximum score of 100 points (15 minutes).

Time frame
Baseline, Week2, Week4, Week12, Week24
3

change from baseline in quality of life score

Quality of life questionnaire will be measured to compare the change in individual's health-related quality of life using face to face Interview for the scores. Higher scores mean better functioning or fewer symptoms.

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

Shanghai Jiao Tong University Affiliated Sixth People's Hospital

Collaborator

Source ClinicalTrials.gov

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