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Completed

NCT Number: NCT04908839

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amélie YAvchitz, Paris, Île-de-France Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

spot-25 questionnaire

Other

spot-25 questionnaire

Primary outcomes

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

    Time frame: 1 DAY

    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.

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: QOLOTOSC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 1, 2021
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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