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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: John O'Neill
- Telefonnummer: 4405062611
- E-post: ONEILLJ2@ccf.org
Studera Kontakt Backup
- Namn: Christopher Novicky
- Telefonnummer: 216-444-7018
- E-post: novickc@ccf.org
Studieorter
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44195
- Rekrytering
- The Cleveland Clinic
-
Kontakt:
- John O'Neill
- Telefonnummer: 4405062611
- E-post: ONEILLJ2@ccf.org
-
Kontakt:
- Hana Rosen
- Telefonnummer: 216-444-7018
- E-post: rosenh@ccf.org
-
Huvudutredare:
- Mohamad Chaaban
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
|
Aktiv komparator: 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.
|
|
Inget ingripande: Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)
No loss of smell CRS with nasal polyps (CRSwNP)
|
|
|
Inget ingripande: Control Group 2: -no loss of smell / no CRS/no polyps
No loss of smell / no CRS/no polyps
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mohamad Chaaban, MD, The Cleveland Clinic
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IRB #24-1122
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