Sudden Sensorineural Hearing Loss (SSNHL)Phase 2NCT03255473
High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
A Phase 2 study testing Dexamethasone and Prednisone in people with Sudden Sensorineural Hearing Loss (SSNHL), run by University of Colorado, Denver at 1 site in United States.
Trial summary
Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Sudden Sensorineural Hearing Loss (SSNHL)
- What is being tested?
- Dexamethasone and Prednisone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 13 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Compare hearing outcomes between treatment with dexamethasone versus prednisone in participants who have been diagnosed with unilateral SSNHL (sudden sensorineural hearing loss).
Read the 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.
- Being tested
- Dexamethasone, Prednisone
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called dexamethasone sodium phosphate
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.
PrednisoneDrug
Also called Deltasone
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.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Active comparator | 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. Receives: Drug: Dexamethasone |
| Prednisone | Active comparator | 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. Receives: Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Hearing Threshold (Hearing Improvement)
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.
Measured: Baseline, 1 week, 1 month, 3 months
Secondary outcomes (4)
Changes in Word Recognition Scores
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.
Measured: 1 week, 1 month, 3 months, and assessed for change from baseline score.
Changes in Pure Tone Averages
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.
Measured: 1 week, 1 month, 3 months, and assessed for change from baseline pure tone average..
Clinical Frequency Analysis Based on Hearing Improvement
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.
Measured: Baseline, 1 week, 1 month, 3 months
Clinical Percentage Analysis Based on Hearing Improvement
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.
Measured: Baseline, 1 week, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start30 Aug 2017
- Primary completion1 Aug 2022
- Study completion13 Mar 2023
Why it stopped: On hold due to COVID-19 outbreak
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Sensorineural Hearing Loss (SSNHL)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen P Cass, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255473
- Sponsor's protocol ID
- 16-2342
- Status last verified
- Oct 2024
- First submitted
- 16 Aug 2017
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Dose Oral Steroids in Sudden Sensorineural Hearing Loss
- ClinicalTrials.gov ID
- NCT03255473
- Acronym / sponsor ID
- 16-2342
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: On hold due to COVID-19 outbreak
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 21 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Active comparator | Drug: DexamethasoneAll 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. |
| Prednisone | Active comparator | Drug: PrednisoneAll subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Present with primary complaint of sensorineural hearing loss
Key exclusion criteria (28 listed)
- Participants for whom high dose corticosteroids are a contraindicated due to:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneAlso: dexamethasone sodium phosphateAll 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 | Dexamethasone |
| PrednisoneAlso: DeltasoneAll 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 |
Primary outcome
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.
4 secondary outcomes
Changes in Word Recognition Scores
Time frame: 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..
Clinical Frequency Analysis Based on Hearing Improvement
Time frame: Baseline, 1 week, 1 month, 3 months
Clinical Percentage Analysis Based on Hearing Improvement
Time frame: Baseline, 1 week, 1 month, 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen P Cass, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone and Prednisone in people with Sudden Sensorineural Hearing Loss (SSNHL), run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Hearing Threshold (Hearing Improvement) (time frame: Baseline, 1 week, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.