Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
- Conditions
- Otosclerosis
- Interventions
- Other: spot-25 questionnaire
- Registration Number
- NCT04908839
- Lead Sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
-
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
- Comorbidity that may interfere with the interpretation of results
- History of stapes surgery
- Person benefiting from a legal protection measure
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description controle: Absence of known otological pathology spot-25 questionnaire Absence of known otological pathology case: patient with otosclerosis spot-25 questionnaire Diagnosis of otosclerosis with indication for primary stapedial surgery by the combination of arguments case: otosclerosis patient with surgery spot-25 questionnaire otosclerosis patient with surgery
- Primary Outcome Measures
Name Time Method Comparison of the total score of cases and controls for the French version of the SPOT-25 questionnaire 1 DAY The SPOT-25 questionnaire includes 25 items and can be divided into 4 subscores: hearing function (items 1-10), tinnitus (items 11-13), mental condition (items 14-19), and social restrictions (items 20-24). In addition, 1 item focuses on the general evaluation of the impact of otosclerosis on HRQOL (item 25). Each question needs to be rated on a six-point ordinal scale from 0 (i.e., no impact) to 5 (i.e., most severe impact), depending on the level of inconvenience or frequency of symptoms.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Amélie YAvchitz
🇫🇷Paris, Ile-de-France, France
Fondation Adolphe de Rothschild
🇫🇷Paris, France