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

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.

Study Overview

• Status: Completed
• Conditions: Otosclerosis
• Intervention / Treatment: Other: spot-25 questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation Adolphe de Rothschild
  • Ile-de-France
    • Paris, Ile-de-France, France, 75019
      • Amélie YAvchitz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case: patient with otosclerosis; Diagnosis of otosclerosis with indication for primary stapedial surgery by the combination of arguments	Other: spot-25 questionnaire; spot-25 questionnaire
case: otosclerosis patient with surgery; otosclerosis patient with surgery	Other: spot-25 questionnaire; spot-25 questionnaire
controle: Absence of known otological pathology; Absence of known otological pathology	Other: spot-25 questionnaire; spot-25 questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2021
• Primary Completion (ACTUAL): April 6, 2022
• Study Completion (ACTUAL): April 6, 2022

Study Registration Dates

• First Submitted: May 26, 2021
• First Submitted That Met QC Criteria: May 26, 2021
• First Posted (ACTUAL): June 1, 2021

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 11, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: SPOT-25
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis
• Other Study ID Numbers: MDL _2021_12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No