Sudden DeafnessPhase 3SSNHLNCT00097448
Sudden Deafness Treatment Trial
A Phase 3 study testing prednisone and methylprednisolone sodium succinate in people with Sudden Deafness, run by Massachusetts Eye and Ear Infirmary at 14 sites in United States.
Trial summary
This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Deafness
- What is being tested?
- prednisone and methylprednisolone sodium succinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 14 sitesUnited States
- Study dates
- Dec 2004to Mar 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men/women 18 years and older in good health
- Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)
- Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies
- Symmetric hearing prior to onset of SSNHL
- Hearing loss must be idiopathic
- Hearing loss must have occurred within the past 14 days
- Must be able to read or write English or Spanish
Who cannot join
- SYSTEMIC DISEASE
- >21 days prior oral steroid treatment within preceding 30 days
- History of tuberculosis (TB) or positive PPD
- Insulin-dependent diabetes mellitus
- History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.
- Serious psychiatric disease or psychiatric reaction to corticosteroids
Show all 27Show fewer
- History of heart disease or transient ischemic attacks (TIAs)
- Prior treatment with chemotherapeutic or immunosuppressive drugs
- Pancreatitis
- Active peptic ulcer disease or history of gastrointestinal bleeding
- History of HIV, Hepatitis B or C
- Chronic kidney failure
- Alcohol abuse
- Active shingles
- Severe osteoporosis or non-surgical aseptic necrosis of the hip
- OTOLOGIC DISEASE
- Prior history of SSNHL
- History of fluctuating hearing loss
- History of Meniere's disease
- History of chronic ear infection
- History of otosclerosis
- History of ear surgery (except childhood pressure equalization [pe] tubes)
- History of congenital hearing loss
- History of trauma immediately preceding onset of SSNHL
- History of syphilitic hearing loss
- History of genetic/hereditary hearing loss
- Skull, facial, or temporal bone anomalies
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48109-0312
Johns Hopkins University
Baltimore, Maryland, 21287-0910
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, 02114
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Michigan Ear Institute
Farmington Hills, Michigan, 48334
University of Florida, College of Medicine
Gainesville, Florida, 32610
Baylor College of Medicine
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242-1078
House Ear Institute
Los Angeles, California, 90057
New York Eye and Ear Infirmary
New York, New York, 10003
New York University School of Medicine
New York, New York, 10016
University of California San Diego
San Diego, California, 92103-8895
Washington University School of Medicine
St Louis, Missouri, 63110
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Sudden Hearing Loss Multicenter Treatment Trial
This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).
Read the detailed description
Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.
- Conditions
- Sudden Deafness
- Being tested
- prednisone, methylprednisolone sodium succinate
- Keywords
- sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss
- 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.
prednisoneDrug
Oral, 19 days
methylprednisolone sodium succinateDrug
Four intratympanic injections delivered to the middle ear over 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Nineteen days of oral prednisone Receives: Drug: prednisone |
| 2 | Experimental | Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks Receives: Drug: methylprednisolone sodium succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing Improvement
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2004 (estimated)
- Study startDec 2004
- Primary completionOct 2009
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sudden DeafnessStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Steven Rauch, MD, Massachusetts Eye and Ear Infirmary
- Investigators
- Steven Rauch, MD, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00097448
- Sponsor's protocol ID
- DC006296
- Other IDs
- U01DC006296, 03-11-055
- Acronym
- SSNHL
- Status last verified
- Apr 2017
- First submitted
- 23 Nov 2004
- Last updated
- 4 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Halpin C, Shi H, Reda D, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Slattery WH, Telian SA, Vrabec JT, Rauch S. Audiology in the sudden hearing loss clinical trial. Otol Neurotol. 2012 Aug;33(6):907-11. doi: 10.1097/MAO.0b013e31825d9a44.
PubMed 22805100Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.
PubMed 21610239
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sudden Hearing Loss Multicenter Treatment Trial
- ClinicalTrials.gov ID
- NCT00097448
- Acronym / sponsor ID
- SSNHL / DC006296
- Conditions
- Sudden Deafness
- Keywords
- sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Dec 2004
- Primary completion
- Oct 2009 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 24 Nov 2004 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial aims to compare the efficacy of oral prednisone vs. methylprednisolone injected into the middle ear for the treatment of moderate-to-severe, sudden sensorineural hearing loss (inner ear hearing loss affecting one ear that occurs over less than 72 hours).
Detailed description
Sudden deafness is believed to affect 1:5000 people yearly. The cause is unknown. Spontaneous improvement is seen in approximately 20% of subjects. Improvement is seen in approximately 60% of subjects treated promptly with oral corticosteroids. Anecdotal case reports and uncontrolled case series have suggested the intratympanic corticosteroids may work as well or better than oral treatment. The risks of oral prednisone are well-known. In theory, intratympanic treatment should achieve a higher drug concentration at the target (inner ear) with less risk of systemic side effects. This study is a head-to-head comparison of oral prednisone vs. intratympanic methylprednisolone for primary treatment of idiopathic sudden deafness. The study is designed as a non-inferiority trial testing that hypothesis that intratympanic methylprednisolone is not inferior to oral prednisone treatment. Subjects assigned to the oral treatment arm receive 14 days of high dose prednisone (60mg/day) followed by a 5-day taper. Subjects assigned to the intratympanic treatment arm receive 4 doses of methylprednisolone injected into the middle twice weekly for two weeks. The primary outcome measure is hearing as measured by pure tone audiometry. Secondary outcomes include word recognition hearing levels and safety issues of local vs. systemic steroid side-effects and pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: prednisoneNineteen days of oral prednisone |
| 2 | Experimental | Drug: methylprednisolone sodium succinateFour doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men/women 18 years and older in good health
- Unilateral sensorineural hearing loss developing within 72 hours (SSNHL)
- Pure Tone Average (PTA) (500, 1000, 2000, 4000 Hz) >/= 50 dB in the affected ear, with the affected ear >/= 30 dB worse than contralateral ear in at least one of the four frequencies
- Symmetric hearing prior to onset of SSNHL
- Hearing loss must be idiopathic
Key exclusion criteria (27 listed)
- SYSTEMIC DISEASE
- >21 days prior oral steroid treatment within preceding 30 days
- History of tuberculosis (TB) or positive PPD
- Insulin-dependent diabetes mellitus
- History of rheumatic disease, e.g., rheumatoid arthritis, scleroderma, lupus, etc.
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 |
|---|---|---|
| prednisoneOral, 19 days | Drug | 1 |
| methylprednisolone sodium succinateFour intratympanic injections delivered to the middle ear over 2 weeks | Drug | 2 |
Primary outcome
Hearing Improvement
Time frame: 2 months
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22805100Halpin C, Shi H, Reda D, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Slattery WH, Telian SA, Vrabec JT, Rauch S. Audiology in the sudden hearing loss clinical trial. Otol Neurotol. 2012 Aug;33(6):907-11. doi: 10.1097/MAO.0b013e31825d9a44.
- Derived from this study: PubMed 21610239Rauch SD, Halpin CF, Antonelli PJ, Babu S, Carey JP, Gantz BJ, Goebel JA, Hammerschlag PE, Harris JP, Isaacson B, Lee D, Linstrom CJ, Parnes LS, Shi H, Slattery WH, Telian SA, Vrabec JT, Reda DJ. Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial. JAMA. 2011 May 25;305(20):2071-9. doi: 10.1001/jama.2011.679.
- Sudden DeafnessLink provided by the sponsor.
Related trials for Sudden Deafness
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Not yet recruitingPhase 3
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingPhase 4
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
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.
Steven Rauch, MD principal investigator
Massachusetts Eye and Ear Infirmary
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prednisone and methylprednisolone sodium succinate in people with Sudden Deafness, run by Massachusetts Eye and Ear Infirmary at 14 sites 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 7 inclusion and 27 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: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hearing Improvement (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00097448, which also lists 2 linked publications.
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 4 Apr 2017.