Skip to content

Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)

Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04908839
Acronym
QOLOTOSC
Enrollment
150
Registered
2021-06-01
Start date
2021-09-09
Completion date
2022-04-06
Last updated
2023-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otosclerosis

Keywords

SPOT-25

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.

Interventions

OTHERspot-25 questionnaire

spot-25 questionnaire

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the total score of cases and controls for the French version of the SPOT-25 questionnaire1 DAYThe 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026