Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training (CIPOD)
A research study to assess the baseline olfactory function, mental health status, clinical severity, and immunological profile in patients with smell loss. The impact of a 3-month olfactory training program on smell function, immunological changes, and mental health in patients with smell loss will be evaluated.
The primary purpose of this study is to investigate tissue and blood samples to identify molecules that may be related to smell loss, ultimately aiming to develop future treatments for this condition and correlate with cognition.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Adult patients with chronic rhinosinusitis (CRS) with nasal polyps and those experiencing loss of smell will be recruited for the study, along with healthy control participants. We will exclude individuals with unilateral nasal polyps, autoimmune diseases, ciliary disorders, cystic fibrosis, or smell loss due to tumors or trauma.
Assessments will be conducted at baseline and again three months after smell training to evaluate changes in olfactory function. Control patients will only undergo baseline testing with no follow-up assessments needed.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: John O'Neill
- Numéro de téléphone: 4405062611
- E-mail: ONEILLJ2@ccf.org
Sauvegarde des contacts de l'étude
- Nom: Christopher Novicky
- Numéro de téléphone: 216-444-7018
- E-mail: novickc@ccf.org
Lieux d'étude
-
-
Ohio
-
Cleveland, Ohio, États-Unis, 44195
- Recrutement
- The Cleveland Clinic
-
Contact:
- John O'Neill
- Numéro de téléphone: 4405062611
- E-mail: ONEILLJ2@ccf.org
-
Contact:
- Hana Rosen
- Numéro de téléphone: 216-444-7018
- E-mail: rosenh@ccf.org
-
Chercheur principal:
- Mohamad Chaaban
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age less than 18 years-old
- Present to rhinology clinic with CRS with nasal polyps
- Sense of smell loss for any reason (other than trauma or tumor)
Exclusion Criteria:
- Patients < 18 years of age
- Individuals with unilateral nasal polyps
- Autoimmune diseases
- Ciliary disorders
- Cystic fibrosis
- Smell loss due to tumors or trauma
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Group 1: - loss of smell + CRS with nasal polyps (CRSwNP)
Loss of smell + CRS with nasal polyps (CRSwNP)
|
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
|
|
Comparateur actif: Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training
Loss of smell + CRS with nasal polyps (CRSwNP) - undergo 3 months of smell training
|
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
|
|
Aucune intervention: Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)
No loss of smell CRS with nasal polyps (CRSwNP)
|
|
|
Aucune intervention: Control Group 2: -no loss of smell / no CRS/no polyps
No loss of smell / no CRS/no polyps
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
Délai: Baseline
|
At baseline, participants will complete the University of Pennsylvania Smell Identification Test (UPSIT), a standardized 40-item scratch-and-sniff odor identification test. Scores range from 0 to 40, with higher scores indicating better olfactory function. Unit of Measure: Score on a scale from 0 to 40. |
Baseline
|
|
Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score
Délai: Baseline
|
At baseline, participants will complete the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS), which measures the negative psychosocial impact of olfactory dysfunction. Scores range from 0 to 48, with higher scores indicating greater negative impact of smell loss on quality of life. Unit of Measure: Score on a scale from 0 to 48. |
Baseline
|
|
Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score
Délai: Baseline
|
At baseline, participants will complete the Mini-Mental State Examination (MMSE), an 11-question cognitive screening tool. Scores range from 0 to 30, with higher scores indicating better cognitive function. Unit of Measure: Score on a scale from 0 to 30. |
Baseline
|
|
Primary Outcome Measure 4: Baseline nasal cytokine concentration
Délai: Baseline
|
At baseline, nasal secretions will be collected from the middle meatus using a polyvinyl alcohol (PVA) sponge and analyzed for cytokine concentrations by multiplex immunoassay. Each cytokine concentration will be reported separately and will not be combined with questionnaire or cognitive assessment scores. Unit of Measure: pg/mL for each cytokine concentration reported separately. |
Baseline
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
Délai: Baseline to Month 3
|
Change from baseline to Month 3 in olfactory function will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT), a standardized 40-item scratch-and-sniff odor identification test.
Scores range from 0 to 40, with higher scores indicating better olfactory function.
Unit of Measure: Change in score on a scale from 0 to 40.
|
Baseline to Month 3
|
|
Secondary Outcome Measure 2: Change from baseline to Month 3 in quality-of-life impact of olfactory dysfunction measured by QOD-NS score
Délai: Baseline to Month 3
|
Change from baseline to Month 3 in the negative psychosocial impact of olfactory dysfunction will be assessed using the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS).
Scores range from 0 to 48, with higher scores indicating greater negative impact of smell loss on quality of life.
Unit of Measure: Change in score on a scale from 0 to 48.
|
Baseline to Month 3
|
|
Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score
Délai: Baseline to Month 3
|
Change from baseline to Month 3 in cognitive function will be assessed using the Mini-Mental State Examination (MMSE), an 11-question cognitive screening tool.
Scores range from 0 to 30, with higher scores indicating better cognitive function.
Unit of Measure: Change in score on a scale from 0 to 30.
|
Baseline to Month 3
|
|
Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration
Délai: Baseline to Month 3
|
Change from baseline to Month 3 in nasal cytokine concentration will be assessed.
Nasal secretions will be collected from the middle meatus using a polyvinyl alcohol (PVA) sponge and analyzed by multiplex immunoassay.
Each cytokine concentration will be reported separately.
Unit of Measure: Change in pg/mL.
|
Baseline to Month 3
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mohamad Chaaban, MD, The Cleveland Clinic
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Manifestations neurologiques
- Maladies du système nerveux
- Conditions pathologiques, anatomiques
- Maladies des voies respiratoires
- Maladies du nez
- Maladies oto-rhino-laryngologiques
- Troubles des sensations
- Polypes
- Troubles olfactifs
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Anosmie
- Polypes nasaux
- Thérapeutique
- Formation olfactive
Autres numéros d'identification d'étude
- IRB #24-1122
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .