Chronic Otitis MediaCOMQ12-FRNCT04423952
Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR
An observational study of Chronic Otitis Media, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs. The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Chronic Otitis Media
- What is being tested?
- COMQ-12 questionnaire
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2020to 20 May 2020
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.
Who may be able to join
- Minors aged 7 to 15 years (inclusive)
- Patients with chronic otitis media, united or bilateral
- Controls: subjects without chronic otitis media or any other pathology of the ear at the time of Inclusion or in background
- holders of parental authority not opposed to participation in the study
Who cannot join
- Non-comprehension of french
Trial locations and contacts
1 site in 1 country.
About this study
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.
The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent.
Read more
The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.
The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.
The objective of this study is to translate and validate the test in French in children.
Read the detailed description
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.
The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is often recurrent.
The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.
The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.
The original version of the COMQ12 questionnaire, in English, was developed by Phillips et al.. The construction of this questionnaire was based on three other questionnaires : the Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and would allow its use in several reputed international centers of otology.
The objective of this study is to translate and validate the test in French in children.
- Conditions
- Chronic Otitis Media
- Being tested
- COMQ-12 questionnaire
- Keywords
- Chronic otitis media in children, Standardized quality of life measurement questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COMQ-12 questionnaireOther
Also called Patient questionnaire
Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic otitis media | Patients aged 7 to 15 years with chronic otitis media. Receives: Other: COMQ-12 questionnaire | |
| Controls | Minors aged 7 to 15 years, with no and no history of chronic otitis. Receives: Other: COMQ-12 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility
Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Measured: 1 year
Consistency reliability test
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Measured: 1 year
Item-total Pearson correlation
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Measured: 1 year
Principal components analysis
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start20 May 2020
- Primary completion20 May 2020
- Study completion20 May 2020
Why it stopped: The study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Otitis MediaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Françoise Denoyelle, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423952
- Sponsor's protocol ID
- APHP200195
- Other IDs
- 2019-A00377-50
- Acronym
- COMQ12-FR
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2020
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR
- ClinicalTrials.gov ID
- NCT04423952
- Acronym / sponsor ID
- COMQ12-FR / APHP200195
- Conditions
- Chronic Otitis Media
- Keywords
- Chronic otitis media in children, Standardized quality of life measurement questionnaire
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 20 May 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 9 Jun 2020 (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.
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.
The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent.
The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.
The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.
The objective of this study is to translate and validate the test in French in children.
Detailed description
The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.
The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is often recurrent.
The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.
The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.
The original version of the COMQ12 questionnaire, in English, was developed by Phillips et al.. The construction of this questionnaire was based on three other questionnaires : the Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and would allow its use in several reputed international centers of otology.
The objective of this study is to translate and validate the test in French in children.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic otitis media | – | Other: COMQ-12 questionnairePatients aged 7 to 15 years with chronic otitis media. |
| Controls | – | Other: COMQ-12 questionnaireMinors aged 7 to 15 years, with no and no history of chronic otitis. |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients followed by the department of otolaryngology and cervico-facial surgery of Necker-Enfants Malades hospital and siblings for the control subjects.
Key inclusion criteria (4 listed)
- Minors aged 7 to 15 years (inclusive)
- Patients with chronic otitis media, united or bilateral
- Controls: subjects without chronic otitis media or any other pathology of the ear at the time of Inclusion or in background
- holders of parental authority not opposed to participation in the study
Key exclusion criteria (1 listed)
- Non-comprehension of french
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 |
|---|---|---|
| COMQ-12 questionnaireAlso: Patient questionnaireSubjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media. | Other | Controls, Patients with chronic otitis media |
Primary outcome
Reproducibility
Time frame: 1 year
Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Consistency reliability test
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Item-total Pearson correlation
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Principal components analysis
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls. COMQ12 : Chronic Otitis Media Questionnaire 12. Score range from 0 to 110 (0 is the score in the absence of symptoms, 110 the worst possible).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Françoise Denoyelle, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Otitis Media, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 4 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was withdrawn before enrolling participants, so there are no results.
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?
Reproducibility (time frame: 1 year). The study lists 4 primary outcomes in all. 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 25 Sep 2025.