Sudden Deafness Treatment Trial (SSNHL)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00097448
First received: November 23, 2004
Last updated: February 27, 2013
Last verified: February 2013

November 23, 2004
February 27, 2013
December 2004
October 2009   (final data collection date for primary outcome measure)
Hearing Improvement [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Change from baseline to 2mos of 4-frequency (500, 1000, 2000, 4000Hz) pure tone average.
hearing improvement
Complete list of historical versions of study NCT00097448 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sudden Deafness Treatment Trial
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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Sudden Deafness
  • Drug: prednisone
    Oral, 19 days
  • Drug: methylprednisolone sodium succinate
    Four intratympanic injections delivered to the middle ear over 2 weeks
  • 1
    Nineteen days of oral prednisone
    Intervention: Drug: prednisone
  • Experimental: 2
    Four doses of methylprednisolone sodium succinate delivered by injection to the middle ear over 2 weeks
    Intervention: Drug: methylprednisolone sodium succinate

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
March 2011
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00097448
DC006296, U01DC006296, 03-11-055
Yes
Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Steven Rauch, MD Massachusetts Eye and Ear Infirmary
Massachusetts Eye and Ear Infirmary
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP