Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
NCT ID: NCT04908839
Last Updated: 2023-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2021-09-09
2022-04-06
Brief Summary
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* Audiometry (as part of the treatment, only for cases)
* Clinical evaluation (within the framework of care, only for cases)
* Passage of the French version of the SPOT-25 questionnaire
Visit 1 (D0 + 3 ± 1 week): only for cases Second examination of the French version of the SPOT-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.
Visit 2 (3-6 months postoperatively): only for operated patients Third examination of the French version of the SPOT-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.
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Detailed Description
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* Audiometry (as part of the treatment, only for cases)
* Clinical evaluation (within the framework of care, only for cases)
* Passage of the French version of the SPOT-25 questionnaire
Visit 1 (D0 + 3 ± 1 week): only for cases Second examination of the French version of the SPOT-25 questionnaire (re-test) either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.
Visit 2 (3-6 months postoperatively): only for operated patients Third examination of the French version of the SPOT-25 questionnaire either by telephone and e-mail, or during a consultation or hospitalization, if this occurs within a compatible time frame.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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case: patient with otosclerosis
Diagnosis of otosclerosis with indication for primary stapedial surgery by the combination of arguments
spot-25 questionnaire
spot-25 questionnaire
case: otosclerosis patient with surgery
otosclerosis patient with surgery
spot-25 questionnaire
spot-25 questionnaire
controle: Absence of known otological pathology
Absence of known otological pathology
spot-25 questionnaire
spot-25 questionnaire
Interventions
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spot-25 questionnaire
spot-25 questionnaire
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of otosclerosis with indication for primary stapes surgery by the combination of the arguments:
* Clinical: normal eardrum and audiometry revealing conductive or mixed hearing loss with audiometric Rinne of\> 15 dB and absence of stapedial reflex.
* Radiological: otosclerotic foci on preoperative CT scan
* Non-opposition to participating in the study
* Good understanding of French
* Affiliate or beneficiary of a health insurance plan
* Person aged\> 18 years
* Absence of known otological pathology
* Without otological surgical history
* Non-opposition to participating in the study
* Good understanding of French
Exclusion Criteria
* History of stapes surgery
* Person benefiting from a legal protection measure
18 Years
ALL
Yes
Sponsors
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Fondation Ophtalmologique Adolphe de Rothschild
NETWORK
Responsible Party
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Locations
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Fondation Adolphe de Rothschild
Paris, , France
Amélie YAvchitz
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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MDL _2021_12
Identifier Type: -
Identifier Source: org_study_id
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