Clinical Trial: Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Acetylcystein Vid Stapedotomi

Brief Summary:

In otosclerosis, one of the tiny bones of the middle ear is unable to move normally. Sounds cannot be transferred to the inner ear and a conductive hearing loss ensues. The disorder is usually treated by an operation where the bone is replaced by a prosthesis. This restores hearing at low sound frequencies. At high frequencies, surgery is less effective. The smaller effect at high frequencies is probably caused by surgically induced inner ear damage.

Animal studies have shown that the drug acetylcysteine can protect the inner ear against damage. It is not known whether the drug has similar effects in humans. This study will assess the efficacy of acetylcysteine in patients undergoing surgery for otosclerosis.

Detailed Summary:
Sponsor: Karolinska University Hospital

Current Primary Outcome: Hearing thresholds [ Time Frame: one year ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome: Self-reported vertigo and tinnitus [ Time Frame: one year ]

Information By: Karolinska University Hospital

Dates:
Date Received: September 4, 2007
Date Started: September 2007
Date Completion:
Last Updated: September 10, 2013
Last Verified: September 2013