OtosclerosisQOLOTOSCNCT04908839
Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
An observational study of Otosclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
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)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Otosclerosis
- What is being tested?
- spot-25 questionnaire
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Sep 2021to 6 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with otosclerosis and person with a known Absence of otological pathology
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Comorbidity that may interfere with the interpretation of results
- History of stapes surgery
- Person benefiting from a legal protection measure
Trial locations and contacts
2 sites in 1 country.
France2 sites
Fondation Adolphe de Rothschild
Paris, 75019
Amélie YAvchitz
Paris, Île-de-France Region, 75019
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.
Read the 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.
- Conditions
- Otosclerosis
- Being tested
- spot-25 questionnaire
- Keywords
- SPOT-25
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spot-25 questionnaireOther
spot-25 questionnaire
| Study group | Role | What they receive |
|---|---|---|
| case: patient with otosclerosis | Diagnosis of otosclerosis with indication for primary stapedial surgery by the combination of arguments Receives: Other: spot-25 questionnaire | |
| case: otosclerosis patient with surgery | otosclerosis patient with surgery Receives: Other: spot-25 questionnaire | |
| controle: Absence of known otological pathology | Absence of known otological pathology Receives: Other: spot-25 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 DAY
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start9 Sep 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908839
- Sponsor's protocol ID
- MDL _2021_12
- Acronym
- QOLOTOSC
- Status last verified
- Feb 2023
- First submitted
- 26 May 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
- ClinicalTrials.gov ID
- NCT04908839
- Acronym / sponsor ID
- QOLOTOSC / MDL _2021_12
- Conditions
- Otosclerosis
- Keywords
- SPOT-25
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| case: patient with otosclerosis | – | Other: spot-25 questionnaireDiagnosis of otosclerosis with indication for primary stapedial surgery by the combination of arguments |
| case: otosclerosis patient with surgery | – | Other: spot-25 questionnaireotosclerosis patient with surgery |
| controle: Absence of known otological pathology | – | Other: spot-25 questionnaireAbsence of known otological pathology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with otosclerosis and person with a known Absence of otological pathology
Key inclusion criteria (12 listed)
- Patient aged> 18 years
- Diagnosis of otosclerosis with indication for primary stapes surgery by the combination of the arguments:
- Non-opposition to participating in the study
- Good understanding of French
- Affiliate or beneficiary of a health insurance plan
Key exclusion criteria (3 listed)
- Comorbidity that may interfere with the interpretation of results
- History of stapes surgery
- Person benefiting from a legal protection measure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spot-25 questionnairespot-25 questionnaire | Other | case: otosclerosis patient with surgery, case: patient with otosclerosis, controle: Absence of known otological pathology |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otosclerosis, run by Fondation Ophtalmologique Adolphe de Rothschild at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the total score of cases and controls for the French version of the SPOT-25 questionnaire (time frame: 1 DAY). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.