Clinical trial NCT04908839: Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
Official title: Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Otosclerosis
Keywords: SPOT-25
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2021-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with otosclerosis and person with a known Absence of otological pathology

Brief summary: Inclusion (J0):

* 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.

Detailed description: Inclusion (J0):

* 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.

Eligibility criteria: Inclusion Criteria:

* Patient aged\> 18 years
* 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

Inclusion criteria for witnesses:

* 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:

* Comorbidity that may interfere with the interpretation of results
* History of stapes surgery
* Person benefiting from a legal protection measure

Primary outcomes:
measure: Comparison of the total score of cases and controls for the French version of the SPOT-25 questionnaire
timeFrame: 1 DAY
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Amélie YAvchitz
state: Ile-de-France
city: Paris
country: France
facility: Fondation Adolphe de Rothschild
Study officials:
References: