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

NCT04908839 | Completed

• 1 other identifier: MDL _2021_12
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

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.

Conditions

Otosclerosis

Keywords

SPOT-25

Outcome Measures

Primary Outcomes (1)

• Comparison of the total score of cases and controls for the French version of the SPOT-25 questionnaire

  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.

  1 DAY

Study Arms (3)

case: patient with otosclerosis

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

Other: spot-25 questionnaire

case: otosclerosis patient with surgery

otosclerosis patient with surgery

Other: spot-25 questionnaire

controle: Absence of known otological pathology

Absence of known otological pathology

Other: spot-25 questionnaire

Interventions

spot-25 questionnaire OTHER

spot-25 questionnaire

case: otosclerosis patient with surgery; case: patient with otosclerosis; controle: Absence of known otological pathology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with otosclerosis and person with a known Absence of otological pathology

You may qualify if:

• 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
• Person aged\> 18 years
• Absence of known otological pathology
• Without otological surgical history
• Non-opposition to participating in the study
• Good understanding of French

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (2)

Fondation Adolphe de Rothschild

Paris, 75019, France

Location

Amélie YAvchitz

Paris, Île-de-France Region, 75019, France

Location

MeSH Terms

Conditions

Otosclerosis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: September 9, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

FR (2)