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High Dose Oral Steroids in Sudden Sensorineural Hearing Loss

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ClinicalTrials.gov Identifier: NCT03255473
Recruitment Status : Recruiting
First Posted : August 21, 2017
Last Update Posted : July 28, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE August 16, 2017
First Posted Date  ICMJE August 21, 2017
Last Update Posted Date July 28, 2021
Actual Study Start Date  ICMJE August 30, 2017
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
Changes in Hearing Threshold (Hearing Improvement) [ Time Frame: Baseline, 1 week, 1 month, 3 months ]
Pure tone averages (from pure tone audiometry) will be recorded for participants at each visit, and assessed for changes in pure tone average over time. Based on a change in pure tone average, participants will be categorized into the different groups.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2017)
  • Changes in Word Recognition Scores [ Time Frame: 1 week, 1 month, 3 months, and assessed for change from baseline score. ]
    Word recognition scores from speech audiometry tests will be summarized, by treatment arm, as a continuous variable using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
  • Changes in Pure Tone Averages [ Time Frame: 1 week, 1 month, 3 months, and assessed for change from baseline pure tone average.. ]
    Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum and will be presented by treatment arm.
  • Clinical Frequency Analysis Based on Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ]
    The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
  • Clinical Percentage Analysis Based on Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ]
    The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2017)
  • Changes in Word Recognition Scores [ Time Frame: Recorded at each visit (1 week, 1 month, 3 months) and assessed for change from baseline score. ]
    Word recognition scores from speech audiometry tests will be summarized, by treatment arm, as a continuous variable using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
  • Changes in Pure Tone Averages [ Time Frame: Recorded at each visit (1 week, 1 month, 3 months) and assessed for change from baseline pure tone average.. ]
    Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum and will be presented by treatment arm.
  • Clinical Frequency Analysis Based on Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ]
    The frequency of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
  • Clinical Percentage Analysis Based on Hearing Improvement [ Time Frame: Baseline, 1 week, 1 month, 3 months ]
    The percentage of patients presenting in each clinical category of hearing improvement will be presented by treatment arm. Hypothesis testing will be performed, using a Mantel-Haenszel Chi-Square test, to test for the association between treatment group and the ordered levels of clinical category of hearing improvement.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Official Title  ICMJE High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Brief Summary Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).
Detailed Description Sudden sensorineural hearing loss (SSNHL) affects approximately 5 to 20 per 100,000 persons with spontaneous recovery seen in 32% to 65%. Many different treatments have been investigated in attempt to improve hearing outcomes, with oral corticosteroids having some success. Steroid regimens are highly variable, however, retrospective data has suggested greater improvement in hearing outcomes with the use of high dose oral steroids (dexamethasone) in the setting of unilateral sudden sensorineural hearing loss compared to traditional medical therapy with lower dose oral prednisone. The investigators hypothesize that patients with unilateral SSNHL who are randomized to treatment with high doses of oral dexamethasone will show better hearing outcomes than patients who are randomized to the more common standard clinical practice treatment with lower doses of oral prednisone.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL within six weeks, and compare side effect profiles between the two treatment regimens of either dexamethasone or prednisone.
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sudden Sensorineural Hearing Loss (SSNHL)
Intervention  ICMJE
  • Drug: Dexamethasone
    All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
    Other Name: dexamethasone sodium phosphate
  • Drug: Prednisone
    All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
    Other Name: Deltasone
Study Arms  ICMJE
  • Active Comparator: Dexamethasone
    All subject identification (ID) numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
    Intervention: Drug: Dexamethasone
  • Active Comparator: Prednisone
    All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
    Intervention: Drug: Prednisone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 18, 2017)
208
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2028
Estimated Primary Completion Date September 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults aged 18 to 80 years old
  • Present to the Otology or Otolaryngology Clinic at the University of Colorado Hospital with unilateral sudden sensorineural hearing loss (SSNHL)
  • Seen within six weeks of initial hearing loss
  • Unilateral hearing loss at screening as defined by:

    • Loss of 30 decibels (dB) HL or greater over 3 continuous frequencies with participants reporting that this hearing loss occurred within 3 days
  • Present with primary complaint of sensorineural hearing loss
  • Normal tympanometry (Type A)
  • Normal tympanic membrane

Exclusion Criteria:

  • Participants for whom high dose corticosteroids are a contraindicated due to:

    • Pregnancy
    • Known allergies to corticosteroids
    • Other concurrent medical conditions and or medications where high dose oral corticosteroids are not safe to use
  • Participants who have Type 1 or Type 2 diabetes
  • Participants who have previously received a course of oral steroids for this indication
  • Participants who have bilateral SSNHL
  • Participants with conductive hearing loss, mixed hearing loss (sensorineural and conductive), or any type of hearing loss that is not SSNHL (i.e. caused by acoustic or physical trauma to the ear)
  • Participants with the following conditions/situations will be excluded because the possibility that these could cause SSNHL:

    • History of previous/recurrent unilateral SSNHL
    • History of fluctuating hearing in either ear
    • History of Meniere's syndrome
    • History of chronic granulomatous or suppurative otitis media or cholesteatoma in either ear
    • History of otosclerosis in either ear
  • Participants with the following conditions/situations will be excluded due to risk of misclassification of diagnosis of idiopathic SSNHL or because these participants are at higher risk for potential steroid side effects due to other comorbidities. If the time line is not otherwise stated, then the participant will be excluded if they experienced these criteria at any point in their lifetime:

    • Received oral steroids (for any indication besides SSNHL) for greater than 21 days in the preceding 30 days
    • Systemic fungal infections in the last 6 months
    • History of tuberculosis or history of prophylactic tuberculosis treatment for positive skin test (PPD)
    • History of unstable angina, coronary artery stenting or bypass graft within 3 months
    • History of transient ischemic attacks, cardiac arrhythmia, or stroke in the last 4 weeks
    • Serious psychiatric disease or history of psychiatric reaction to corticosteroids, specifically bipolar, schizophrenia, episodes of mania or delirium
    • Prior treatment with chemotherapy agents, immunosuppressive drugs, cyclosporine, or interferon
    • Pancreatitis in the last year
    • Active peptic ulcer disease or history of gastrointestinal bleeding in the last year
    • History of known HIV, hepatitis C, or hepatitis B infection
    • Chronic renal insufficiency requiring dialysis
    • Active shingles (herpes zoster infection)
    • Advanced/severe osteoporosis or nonsurgical aseptic necrosis of the hip
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristi Engle Folchert, MA 303-724-9528 kristi.englefolchert@CUAnschutz.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03255473
Other Study ID Numbers  ICMJE 16-2342
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen P Cass, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP