High Dose Oral Steroids in Sudden Sensorineural Hearing Loss

October 10, 2024 updated by: University of Colorado, Denver
Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Deltasone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 1 week, 1 month, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 week, 1 month, 3 months, and assessed for change from baseline score.
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.
1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..
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.
Baseline, 1 week, 1 month, 3 months
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.
Baseline, 1 week, 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen P Cass, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-2342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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