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Sudden Deafness Treatment Trial (SSNHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097448
Recruitment Status : Completed
First Posted : November 24, 2004
Results First Posted : April 4, 2013
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Steven Rauch, MD, Massachusetts Eye and Ear Infirmary

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Sudden Deafness
Interventions Drug: prednisone
Drug: methylprednisolone sodium succinate
Enrollment 255
Recruitment Details Consecutive consenting adults with SSNHL from 16 academic medical centers around the United States.
Pre-assignment Details All subject presenting within 14 days of SSNHL onset.
Arm/Group Title Oral Steroids Intratympanic Steroids
Hide Arm/Group Description Prednisone 60mg per day x 14 days, 5 day taper. 1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
Period Title: Overall Study
Started 125 130
Completed 121 129
Not Completed 4 1
Arm/Group Title Oral Steroids Intratympanic Steroids Total
Hide Arm/Group Description Prednisone 60mg per day x 14 days, 5 day taper. 1ml of methylprednisolone 10mg/ml. 4 doses over 14 days. Total of all reporting groups
Overall Number of Baseline Participants 125 130 255
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 130 participants 255 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
125
 100.0%
130
 100.0%
255
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 125 participants 130 participants 255 participants
50  (14) 51  (15) 50.5  (14.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 125 participants 130 participants 255 participants
Female
51
  40.8%
53
  40.8%
104
  40.8%
Male
74
  59.2%
77
  59.2%
151
  59.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 125 participants 130 participants 255 participants
United States 122 127 249
Canada 3 3 6
1.Primary Outcome
Title Hearing Improvement
Hide Description Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Time Frame 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat
Arm/Group Title Oral Steroids IT Steroids
Hide Arm/Group Description:
Prednisone
methylprednisolone
Overall Number of Participants Analyzed 121 129
Mean (Standard Deviation)
Unit of Measure: dB
30.7  (21.7) 28.7  (21.5)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Oral Steroids IT Steroids
Hide Arm/Group Description Prednisone methylprednisolone
All-Cause Mortality
Oral Steroids IT Steroids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Oral Steroids IT Steroids
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/125 (4.00%)      6/130 (4.62%)    
Blood and lymphatic system disorders     
Leukemia  0/125 (0.00%)  0 1/130 (0.77%)  1
Cardiac disorders     
myocardial infarction  1/125 (0.80%)  1 1/130 (0.77%)  1
Endocarditis  0/125 (0.00%)  0 1/130 (0.77%)  1
Musculoskeletal and connective tissue disorders     
Osteomyelitis  [1]  0/125 (0.00%)  0 1/130 (0.77%)  1
Nervous system disorders     
Cerebral hemorrhage  1/125 (0.80%)  1 0/130 (0.00%)  0
Transient ischemic attack  1/125 (0.80%)  1 0/130 (0.00%)  0
Syncope  1/125 (0.80%)  1 0/130 (0.00%)  0
Renal and urinary disorders     
Bladder cancer  0/125 (0.00%)  0 1/130 (0.77%)  1
Hyponatremia  1/125 (0.80%)  1 0/130 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
COPD exacerbation  0/125 (0.00%)  0 1/130 (0.77%)  1
Indicates events were collected by systematic assessment
[1]
Osteomyelitis of toe
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Oral Steroids IT Steroids
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   121/125 (96.80%)      127/130 (97.69%)    
Ear and labyrinth disorders     
Ear pain   4/125 (3.20%)  4 70/130 (53.85%)  186
Vertigo   13/125 (10.40%)  14 35/130 (26.92%)  49
Eaer infection   2/125 (1.60%)  2 7/130 (5.38%)  7
Tympnaic membrane perforation   0/125 (0.00%)  0 5/130 (3.85%)  5
Endocrine disorders     
Hyperglycemia   36/125 (28.80%)  39 21/130 (16.15%)  21
Appetite change   28/125 (22.40%)  28 6/130 (4.62%)  7
Nervous system disorders     
Sleep disturbance   44/125 (35.20%)  44 9/130 (6.92%)  9
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Steven Rauch
Organization: Massachusetts Eye and Ear Infirmary
Phone: 617-573-1166
EMail: steven_rauch@meei.harvard.edu
Layout table for additonal information
Responsible Party: Steven Rauch, MD, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00097448    
Other Study ID Numbers: DC006296
U01DC006296 ( U.S. NIH Grant/Contract )
03-11-055 ( Other Identifier: Massachusetts Eye and Ear Infirmary )
First Submitted: November 23, 2004
First Posted: November 24, 2004
Results First Submitted: November 8, 2012
Results First Posted: April 4, 2013
Last Update Posted: April 4, 2017