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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Otosclerosis

Treatments: Other: spot-25 questionnaire

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04908839

MDL _2021_12

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 3 patient groups

case: patient with otosclerosis

Description:

Diagnosis of otosclerosis with indication for primary stapedial surgery by the combination of arguments

Treatment:

Other: spot-25 questionnaire

case: otosclerosis patient with surgery

Description:

otosclerosis patient with surgery

Treatment:

Other: spot-25 questionnaire

controle: Absence of known otological pathology

Description:

Absence of known otological pathology

Treatment:

Other: spot-25 questionnaire