A new clinical research study (study # STU00212929; clinicalTrials.gov ID, NCT04826237) in Otolaryngology (the department that focuses on ears, nose and throat) at Northwestern Medicine wants to improve the standard of care for sudden hearing loss by comparing the usual steroid treatment (standard of care) to one that also includes a short-term dose (7-day) of oral statin. Statin is a medication that is already widely used in human medicine to treat high blood cholesterol.
This clinical trial is based on years of preclinical research in two animal models, by Dr. Donna Whitlon’s Research Group showing that short term dosing of statin can protect against hearing loss and protect hearing structures in the ear of these animal models. The results have not yet been tested in humans.
This trial will adhere to strict standards of scientific and clinical investigation.
All research study patients with sudden hearing loss of unknown cause will receive the same standard of care as patients who are not in the study. Standard of care is decreasing doses of an oral steroid for 11 days. If there is no improvement in hearing, then a steroid injection into the middle ear will be offered.
Patients on the study will, in addition, receive a statin or a placebo (contains no drug) to be taken once a day with the oral steroid for 7 days. The experimental treatment (statin or placebo) you will get will be chosen by chance, like flipping a coin. Neither you nor the study doctor will know or choose what treatment you get. You will have an equal chance of being given either treatment. There will be a two-week follow-up, and depending on the outcome, several additional follow-up appointments over up a period of up to 16 weeks for both study and non-study patients. At each follow up, patients will take tests for hearing, speech recognition and for tinnitus (ringing in the ears).
The standard of care is covered by most medical insurance. The cost of the statin or placebo will be covered by the study. Partial compensation for parking costs and time is available to all participants.
Participation is completely voluntary. You can leave the research at any time.