Validation of questionnaires for chronic rhinosinusitis severity and control
CRS Questionnaire Validation Project
This study is testing two new questionnaires to see if they can help people with chronic rhinosinusitis understand how severe their symptoms are and how well they are managing them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The European Forum for Research and Education in Allergy and Airway Diseases Academic / other |
| Locations | 32 sites (Santa Monica, California and 31 other locations) |
| Trial ID | NCT06970977 on ClinicalTrials.gov |
What this trial studies
This project involves a collaboration of 32 medical centers across Europe, the USA, and South Africa to validate two new questionnaires designed to assess the self-perceived severity and control of chronic rhinosinusitis (CRS) with and without nasal polyps. The study aims to recruit 1000 patients from routine ENT practices to ensure a straightforward data collection process. The statistical analysis and report creation will be managed by the University of Leuven's statistical department, comparing the new questionnaires with existing assessment tools.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with chronic rhinosinusitis with or without nasal polyps who can provide informed consent and have not undergone recent sinus surgery.
Not a fit: Patients who have not been diagnosed with chronic rhinosinusitis or have had sinus surgery within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a reliable method for patients and clinicians to assess and manage chronic rhinosinusitis more effectively.
How similar studies have performed: Previous studies have successfully validated similar questionnaires for chronic conditions, suggesting a promising outcome for this validation project.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient capable of giving informed consent * Diagnosis of chronic rhinosinusitis with or without nasal polyposis according to the EPOS guidelines * No recent sinus surgery (within the last three months) Exclusion Criteria: * Not capable of giving informed consent * No CRS * Recent sinus surgery (within the last three months)
Where this trial is running
Santa Monica, California and 31 other locations
- UCLA Santa Monica Medical Center — Santa Monica, California, United States (Recruiting)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
- Brigham Sinus Center at Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
- Eastern Virginia Medical School — Virginia City, Virginia, United States (Recruiting)
- UZ Gent — Ghent, Belgium (Not_yet_recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- St. Michael's Hospital — Toronto, Canada (Recruiting)
- Univ of Copenhagen — Copenhagen, Denmark (Recruiting)
- HNO-Klinik, Universitätsklinikum Düsseldorf — Düsseldorf, Germany (Not_yet_recruiting)
- Univ Munich — Munich, Germany (Not_yet_recruiting)
- University General Hospital of Heraklion — Heraklion, Greece (Recruiting)
- U. Aristotle — Thessaloniki, Greece (Recruiting)
- Univ Hospital Roma — Roma, Italy (Recruiting)
- Univ Amsterdam — Amsterdam, Netherlands (Not_yet_recruiting)
- Alrijne Zorggroep — Leiden, Netherlands (Recruiting)
- University of Oradea — Oradea, Romania (Recruiting)
- Ahmed Alkhadi Hospital — Durban, South Africa (Recruiting)
- Hospital Clínico Universitario de Compostela — A Coruña, Spain (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Recruiting)
- Hospital de la Santa Creu i Sant Pau — Barcelona, Spain (Recruiting)
- Hospital de La Línea de La Concepción — Cadiz, Spain (Recruiting)
- Hospital Universitario Jerez de La Frontera — Cadiz, Spain (Recruiting)
- Hospital Universitario Puerta del Mar — Cadiz, Spain (Recruiting)
- Hospital Universitario Puerto Real — Cadiz, Spain (Recruiting)
- Hospital Universitario Fuenlabrada — Madrid, Spain (Recruiting)
- Hospital Universitario Infanta Elena, Madrid y Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
- Hospital Universitario Ramón y Cajal — Madrid, Spain (Recruiting)
- Hospital del Bierzo — Ponferrada, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla — Santander, Spain (Recruiting)
- Hospital Universitario Virgen Macarena — Seville, Spain (Recruiting)
- Hospital General Universitario de Valencia — Valencia, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.