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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 : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).

Condition or disease Intervention/treatment Phase
Sudden Sensorineural Hearing Loss (SSNHL) Drug: Dexamethasone Drug: Prednisone Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
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
Official Title: High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
Actual Study Start Date : August 30, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : February 2020


Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255473


Contacts
Contact: Kristi Engle Folchert, MA 303-724-9528 kristi.englefolchert@ucdenver.edu

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Kristi Engle Folchert, MA    303-724-9528    kristi.englefolchert@ucdenver.edu   
Principal Investigator: Stephen P Cass, MD         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Stephen P Cass, MD University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03255473     History of Changes
Other Study ID Numbers: 16-2342
First Posted: August 21, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dexamethasone acetate
Dexamethasone
Prednisone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action