Clinical Trial: Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study

Brief 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.

Detailed Summary:

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
Sponsor: University Hospital, Toulouse

Current Primary Outcome: Evolution of the quality of life (scored by GHSI) [ Time Frame: 4th Month ]

The primary outcome is to describe the evolution of the quality of life (scored by the Glasgow Health Status Inventory (GHSI)) during the hearing rehabilitation of otosclerosis frst with an external monaural hearing aid (support for at least 2 months), followed by a surgical treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Evolution of the quality of life (scored by SSQ) [ Time Frame: Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery ]
    Secondary outcomes will be to describe the evolution of the quality of life by specific questionnaires (SSQ APHAB, GBI), the evolution of simple and complex audiometric testing in both managements of otosclerosis. Adverse reactions reported are also analyzed as well as the number of patients refusing surgery after trying hearing aid rehabilitation.
  • Evolution of the quality of life (scored by APHAB) [ Time Frame: Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery ]
    Secondary outcomes will be to describe the evolution of the quality of life by specific questionnaires (SSQ APHAB, GBI), the evolution of simple and complex audiometric testing in both managements of otosclerosis. Adverse reactions reported are also analyzed as well as the number of patients refusing surgery after trying hearing aid rehabilitation.
  • Evolution of the quality of life (scored by GBI) [ Time Frame: Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery ]
    Secondary outcomes will be to describe the evolution of the quality of life by specific questionnaires (SSQ APHAB, GBI), the evolution of simple and complex audiometric testing in both managements of otosclerosis. Adverse reactions reported are also analyzed as well as the number of patients refusing surgery after trying hearing aid rehabilitation.


Original Secondary Outcome: Same as current

Information By: University Hospital, Toulouse

Dates:
Date Received: May 26, 2015
Date Started: September 2015
Date Completion: July 2017
Last Updated: August 16, 2016
Last Verified: August 2016