Chronic RhinosinusitisSN5-FRNCT04117646
Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire
An observational study of Chronic Rhinosinusitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms… Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Sinus and nasal quality of life survey questionnaire (SN-5)
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2020to 11 Jun 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 2 to 12 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
- Non-opposition of the holders of parental authority and the subject to participation in the study
- Subjects between 2 and 12 years of age Patients : - Patients followed in consultation at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery for chronic rhinosinusitis (rhinosinusitis more than 12 weeks)
- Controls :
- Subject without chronic rhinosinusitis at the time of inclusion and without chronic rhinitis history
Who cannot join
- French language not spoken by parents
Trial locations and contacts
1 site in 1 country.
About this study
A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.
The objective of the study is to validate the translation of the SN-5 questionnaire in French.
Read the detailed description
Chronic rhinosinusitis is a common pathology that entrains significant medical consumption. The prevalence of chronic rhinosinusitis in children is estimated to be 7.6%. Cardinal symptoms include nasal congestion, purulent rhinorrhea, facial pain, and persistent daytime cough. All these nasal symptoms often have an impact on the quality of life. The main objective of medical treatment is to improve this quality of life.
The treatment of chronic rhinosinusitis is mainly medical and includes nose washes with physiological serum, topical or general corticosteroid treatment or antibiotics. Surgical treatments such as adenoidectomy or endonasal functional surgery are reserved for medical treatment failures. According to a European consensus paper of 2012, the surgical strategy of the chronic rhinosinusitis of the child must start with a adenoidectomy with physiological serum washes, and then secondarily a endonasal functional surgery.
The ability of quality of life questionnaires to measure subjective symptoms over a certain length of time can help in the medical decision by determining the benefit of taking care. A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.
The objective of the study is to validate the translation of the SN-5 questionnaire in French.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Sinus and nasal quality of life survey questionnaire (SN-5)
- Keywords
- Chronic rhinosinusitis of children, Sinus and nasal quality of life survey questionnaire (SN-5), Translation in French of the SN-5
- Medical subject headings
- Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinus and nasal quality of life survey questionnaire (SN-5)Other
Also called Patient questionnaire
Subjects respond to the translated questionnaire twice at 15 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients of 2 and 12 years of age with chronic rhinosinusitis. Receives: Other: Sinus and nasal quality of life survey questionnaire (SN-5) | |
| Controls | Subjects of 2 and 12 years of age without chronic rhinosinusitis. Receives: Other: Sinus and nasal quality of life survey questionnaire (SN-5) |
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.
Measured: 1 year
Consistency reliability test
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Measured: 1 year
Item-total Pearson correlation
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Measured: 1 year
Principal components analysis
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
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 posted7 Oct 2019
- Study start6 Apr 2020
- Primary completion11 Jun 2020
- Study completion11 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinosinusitisStudies 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
- 89 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
- Nicolas Leboulanger, MD PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117646
- Sponsor's protocol ID
- APHP190791
- Other IDs
- ID RCB : 2019-A00387-50
- Acronym
- SN5-FR
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2019
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gargula S, Luscan R, Drummond D, Denoyelle F, Couloigner V, Leboulanger N, Simon F. French translation and validation of the Sinus and Nasal Quality of Life Survey (SN-5) in children. Int J Pediatr Otorhinolaryngol. 2021 Jun;145:110706. doi: 10.1016/j.ijporl.2021.110706. Epub 2021 Apr 6.
PubMed 33862327
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity of the French Version of the Child's Chronic Rhinosinusitis Questionnaire
- ClinicalTrials.gov ID
- NCT04117646
- Acronym / sponsor ID
- SN5-FR / APHP190791
- Conditions
- Chronic Rhinosinusitis
- Keywords
- Chronic rhinosinusitis of children, Sinus and nasal quality of life survey questionnaire (SN-5), Translation in French of the SN-5
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 11 Jun 2020 (actual)
- Study completion
- 11 Jun 2020 (actual)
- First posted
- 7 Oct 2019 (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.
A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.
The objective of the study is to validate the translation of the SN-5 questionnaire in French.
Detailed description
Chronic rhinosinusitis is a common pathology that entrains significant medical consumption. The prevalence of chronic rhinosinusitis in children is estimated to be 7.6%. Cardinal symptoms include nasal congestion, purulent rhinorrhea, facial pain, and persistent daytime cough. All these nasal symptoms often have an impact on the quality of life. The main objective of medical treatment is to improve this quality of life.
The treatment of chronic rhinosinusitis is mainly medical and includes nose washes with physiological serum, topical or general corticosteroid treatment or antibiotics. Surgical treatments such as adenoidectomy or endonasal functional surgery are reserved for medical treatment failures. According to a European consensus paper of 2012, the surgical strategy of the chronic rhinosinusitis of the child must start with a adenoidectomy with physiological serum washes, and then secondarily a endonasal functional surgery.
The ability of quality of life questionnaires to measure subjective symptoms over a certain length of time can help in the medical decision by determining the benefit of taking care. A single quality questionnaire evaluating the symptoms of chronic rhinosinusitis in children currently exists. It has been validated in English for children aged 2 to 12. It comprises five areas of quality of life, each rated by a score ranging from 1 to 7 : sinus infection, nasal obstruction, allergic symptoms, emotional distress and activity limitation, coupled with an overall assessment of quality of life with an analogue visual scale (score from 1 to 10). This SN-5 (sinus and nasal quality of life survey) score showed excellent statistics of reproducibility, internal validity and ease of response. It is currently used in several international publications evaluating chronic sinus pathology in children.
The objective of the study is to validate the translation of the SN-5 questionnaire in French.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Sinus and nasal quality of life survey questionnaire (SN-5)Patients of 2 and 12 years of age with chronic rhinosinusitis. |
| Controls | – | Other: Sinus and nasal quality of life survey questionnaire (SN-5)Subjects of 2 and 12 years of age without chronic rhinosinusitis. |
Who may qualify
- Ages
- 2 to 12 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)
- Non-opposition of the holders of parental authority and the subject to participation in the study
- Subjects between 2 and 12 years of age Patients : - Patients followed in consultation at Necker Hospital in pediatric department of otolaryngology and cervico-facial surgery for chronic rhinosinusitis (rhinosinusitis more than 12 weeks)
- Subject without chronic rhinosinusitis at the time of inclusion and without chronic rhinitis history
Key exclusion criteria (1 listed)
- French language not spoken by parents
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 |
|---|---|---|
| Sinus and nasal quality of life survey questionnaire (SN-5)Also: Patient questionnaireSubjects respond to the translated questionnaire twice at 15 days apart. | Other | Controls, Patients |
Primary outcome
Reproducibility
Time frame: 1 year
Reproducibility of the questionnaire completed by a subject at 15 days apart. Student t-test.
Consistency reliability test
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Item-total Pearson correlation
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
Principal components analysis
Time frame: 1 year
Measure of efficiency. Comparison of questionnaires completed by patients and controls.
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 11 Mar 2026.
- Results publication: PubMed 33862327Gargula S, Luscan R, Drummond D, Denoyelle F, Couloigner V, Leboulanger N, Simon F. French translation and validation of the Sinus and Nasal Quality of Life Survey (SN-5) in children. Int J Pediatr Otorhinolaryngol. 2021 Jun;145:110706. doi: 10.1016/j.ijporl.2021.110706. Epub 2021 Apr 6.
- 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.
Nicolas Leboulanger, 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 Rhinosinusitis, 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: finished, as of the sponsor's last update on 11 Mar 2026. 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 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?
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?
On the ClinicalTrials.gov record for NCT04117646, which also lists 1 linked publication.
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 11 Mar 2026.