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

Otosclerosis Clinical Trial

— PARCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456272
• Other study ID #: RC31/14/7312
• Secondary ID: 2014-A01764-43
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Nosological criteria:

• Unilateral or bilateral asymmetric otosclerosis

• Conductive hearing loss of at least 30 dB with an average loss Rinne means greater than or equal to 20 dB (on frequencies 0.5, 1, 2, 4 kHz)

• Normal tympanum

• Temporal bones CT-scan showing radiologic signs of otosclerosis

Related to treatment criteria:

• No previous treatment for the otosclerosis

Exclusion Criteria:

Disease's related criteria:

• Far advanced otosclerosis defined as less than 95dB air conduction at all frequencies or lower bone conduction 55dB on at least one frequency

• Cochlear otosclerosis objectified on the temporal bones Ct-scan

• Others clinical or radiological diagnostics: cholesteatoma, tympanic membrane perforation, geyser's syndrome, ossicular dislocation, ossicular malformation, tympanosclerosis.

Associated pathologies: tympanic retraction, effects of chronic otitis, tubal dysfunction.

Criteria about proposed treatments:

• Anesthesia contraindications

• Operative contraindication: clotting disorders, tympanum retraction and tubal dysfunction, geyser's syndrome, single ear, patient refusal.

Criteria relative to study's explorations: Language barrier (questionnaires, tests), cognitive disorders.

Criteria relating to previous treatment: Previous hearing aid or surgery Administrative criteria: Patients minors, incapable adults, adults under guardianship, incapable of giving consent.

Related Conditions & MeSH terms

• Otosclerosis

Intervention

Device:
• External hearing aid
The external hearing aid (monaural) with an auditory prosthesis contour type, brand PHONAK type Bolero Q70 will be provided to the patients during a minimum of 2 months.For reasons of standardization and comparability of results, only one type of prosthesis (medium-high range) will be provided. The settings will be performed by audiologists of ENT service during the inclusion visit.

Procedure:
• Otosclerosis surgery
Surgical restoration of the columellar effect consists of the intraoperative verification of the stapedo-vestibular ankylosis which provides diagnostic. Then a stapedotomy (laser or Ototool°) is performed and partial ossicular prosthesis s inserted between stapedotomy and the long process of the incus.

Locations

Country	Name	City	State
France	Toulouse University Hospital (CHU de Toulouse)	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of the quality of life (scored by GHSI)	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.	4th Month
Secondary	Evolution of the quality of life (scored by SSQ)	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.	Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
Secondary	Evolution of the quality of life (scored by APHAB)	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.	Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
Secondary	Evolution of the quality of life (scored by GBI)	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.	Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery