Clinical Trials Logo

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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04908839 - Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
Completed NCT02901093 - Quantification of Prosthesis Penetration With Conebeam in Otosclerosis N/A
Completed NCT01855425 - Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose N/A
Completed NCT00525551 - Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis Phase 4
Active, not recruiting NCT00222417 - Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease Phase 2/Phase 3
Not yet recruiting NCT06022471 - Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus Using Tinnitogram
Terminated NCT02435446 - Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS) N/A
Terminated NCT01617057 - Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis Phase 3
Recruiting NCT05921578 - Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis. N/A
Not yet recruiting NCT06283836 - Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy N/A
Active, not recruiting NCT05987215 - Interest of Using Deep Learning Algorithm for Otosclerosis Detection on Temporal Bone High Resolution CT
Terminated NCT05214053 - Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis N/A
Completed NCT03888079 - Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
Recruiting NCT06179251 - KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING
Completed NCT02019888 - Wide Frequency Band Test of Hearing in Veterans
Not yet recruiting NCT06221007 - Long-Term Results of Bone Cement in Stapes Surgery
Not yet recruiting NCT05799404 - Stapes Footplate Thickness Measured With UHR-CT
Not yet recruiting NCT06323863 - Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation