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

Otosclerosis Clinical Trial

— QOLOTOSC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04908839
• Other study ID #: MDL _2021_12
• Status: Completed
• Start date: September 9, 2021
• Est. completion date: April 6, 2022

Study information

• Verified date: February 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Otosclerosis

Intervention

Other:
• spot-25 questionnaire
spot-25 questionnaire

Locations

Country	Name	City	State
France	Amélie YAvchitz	Paris	Ile-de-France
France	Fondation Adolphe de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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