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

Primary Purpose

Otosclerosis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
External hearing aid
Otosclerosis surgery
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otosclerosis focused on measuring Otosclerosis, Surgical treatment, Hearing aids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Toulouse University Hospital (CHU de Toulouse)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

External hearing aid & Otosclerosis surgery

Arm Description

Trying an hearing aid for at least two months and then undergo otosclerosis surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 26, 2015
Last Updated
May 30, 2018
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02456272
Brief Title
Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study
Acronym
PARCO
Official Title
Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otosclerosis
Keywords
Otosclerosis, Surgical treatment, Hearing aids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
External hearing aid & Otosclerosis surgery
Arm Type
Experimental
Arm Description
Trying an hearing aid for at least two months and then undergo otosclerosis surgery
Intervention Type
Device
Intervention Name(s)
External hearing aid
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Otosclerosis surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evolution of the quality of life (scored by GHSI)
Description
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.
Time Frame
4th Month
Secondary Outcome Measure Information:
Title
Evolution of the quality of life (scored by SSQ)
Description
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.
Time Frame
Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
Title
Evolution of the quality of life (scored by APHAB)
Description
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.
Time Frame
Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery
Title
Evolution of the quality of life (scored by GBI)
Description
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.
Time Frame
Change and evolution at different time points: baseline, 2-month intervention, 2-month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu MARX, MD
Organizational Affiliation
Toulouse University Hospital (CHU Toulouse)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital (CHU de Toulouse)
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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