Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis:

Status Completed

Clinical Trial Summary

This is a French pilot study in the Toulouse University Hospital that will include a minimum of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.

Clinical Trial Description

Otosclerosis is the main cause of acquired hearing loss in young to middle aged Caucasian population. Social, personal and medico-economic impacts triggered by this affection make it a major public health matter. Historically, the surgical treatment of otosclerosis has always been considered one of the best indications of otologic surgery. The external hearing aid was then an alternative to surgery considered as a more restrictive and less effective management of otosclerosis. With the recent technological developments of hearing aids, comparing these two treatments otosclerosis should be studied. The absence of scientific data from the literature concerning this subject justifies this study which purpose is to describe the evolution of the quality of life and hearing performance of a same patient after taking over by these two approaches.

This is a French pilot study in the Toulouse University Hospital that will include a minimum of 30 patients with proven unilateral or asymmetric otosclerosis. Each one will receive a hearing aid for a minimum of 2 months and then undergo otosclerosis surgery.

The primary outcome will be based on a study of the quality of life (score of 0-100 to quality of life validated questionnaire Glasgow Health Status Inventory (GHSI)). The questionnaire will be given to the patient at the pre-enrollment visit, after a period of two months of external hearing aid trying and 2 months after the surgery. Secondary outcomes will be studied: simple hearing performance (voice and tone audiogram), complex hearing performance (speech audiogram in noise recognition stamp), specific questionnaires for hearing (SSQ), for hearing aids (APHAB, GBI equipment), for tinnitus if present (THI and VAS discomfort / intensity) or for surgical treatment (surgery GBI). Data about treatment's side effects and the number of potential patients refusing surgery after testing the hearing aid will also be collected. ;

Study Design

Related Conditions & MeSH terms

Otosclerosis

Clinical Trial Details

NCT number	NCT02456272
Study type	Interventional
Source	University Hospital, Toulouse
Contact
Status	Completed
Phase	N/A
Start date	September 2015
Completion date	December 2017

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study — PARCO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms