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Intratympanic Steroids for Sudden Hearing Loss

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ClinicalTrials.gov Identifier: NCT04129697
Recruitment Status : Not yet recruiting
First Posted : October 17, 2019
Last Update Posted : October 17, 2019
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
For patients with sudden hearing loss, the initial treatment is not usually effective. We use Dexamethasone or Methylprednisolone to be an Intratympanic steroid administration as a salvage treatment. An randomized, double-blind, multi-center study is designed to find the difference between Dexamethasone or Methylprednisolone.

Condition or disease Intervention/treatment Phase
Dexamethasone or Methylprednisolone; Sudden Hearing Loss; Intratympanic Steroid Drug: Dexamethasone or Methylprednisolone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intratympanic Dexamethasone or Methylprednisolone for Sudden Hearing Loss as a Salvage Treatment: a Randomized, Double-blind, Multi-center Study
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Active Comparator: Dexamethasone Drug: Dexamethasone or Methylprednisolone

Active Comparator: Methylprednisolone Drug: Dexamethasone or Methylprednisolone

Primary Outcome Measures :
  1. hearing [ Time Frame: six month ]
    the hearing level after treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

sudden hearing loss and initial treatment is not effective

Exclusion Criteria:

the patients refused intratympanic steroids treatment.

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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04129697    
Other Study ID Numbers: 2019SHLRCT
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The results of the study could be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Neuroprotective Agents
Protective Agents