Sudden Deafness
Conditions
Keywords
sudden hearing loss, unilateral sudden sensorineural hearing loss, sudden sensorineural hearing loss, sudden unilateral hearing loss
Brief 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).
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.
Interventions
DRUGprednisone
Oral, 19 days
DRUGmethylprednisolone sodium succinate
Four intratympanic injections delivered to the middle ear over 2 weeks
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Improvement | 2 months | Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average. |
Countries
United States
Participant flow
Recruitment details
Consecutive consenting adults with SSNHL from 16 academic medical centers around the United States.
Pre-assignment details
All subject presenting within 14 days of SSNHL onset.
Participants by arm
| Arm | Count |
|---|---|
| Oral Steroids Prednisone 60mg per day x 14 days, 5 day taper. | 125 |
| Intratympanic Steroids 1ml of methylprednisolone 10mg/ml. 4 doses over 14 days. | 130 |
| Total | 255 |
Baseline characteristics
| Characteristic | Oral Steroids | Intratympanic Steroids | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants | 130 Participants | 255 Participants |
| Age, Continuous | 50 years STANDARD_DEVIATION 14 | 51 years STANDARD_DEVIATION 15 | 50.5 years STANDARD_DEVIATION 14.5 |
| Region of Enrollment Canada | 3 participants | 3 participants | 6 participants |
| Region of Enrollment United States | 122 participants | 127 participants | 249 participants |
| Sex: Female, Male Female | 51 Participants | 53 Participants | 104 Participants |
| Sex: Female, Male Male | 74 Participants | 77 Participants | 151 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 121 / 125 | 127 / 130 |
| serious Total, serious adverse events | 5 / 125 | 6 / 130 |
Outcome results
Primary
Hearing Improvement
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
Time frame: 2 months
Population: Intention-to-treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Steroids | Hearing Improvement | 30.7 dB | Standard Deviation 21.7 |
| IT Steroids | Hearing Improvement | 28.7 dB | Standard Deviation 21.5 |