Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25) (NCT04908839) | Clinical Trial Compass
CompletedNot Applicable
Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
France150 participantsStarted 2021-09-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the total score of cases and controls for the French version of the SPOT-25 questionnaire
Timeframe: 1 DAY
Trial details
NCT IDNCT04908839
SponsorFondation Ophtalmologique Adolphe de Rothschild