Chronic Rhinosinusitis (CRS), Smell Loss
Conditions
Keywords
Smell Loss, Chronic Rhinosinusitis, Nasal Polyps, CRSwNP
Brief summary
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.
Detailed description
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.
Interventions
OTHERSmell Training
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
Sponsors
The Cleveland Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
A total of 4 Groups Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) Group 2: - loss of smell with no CRS/no polyps Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) Control Group 2: -no loss of smell / no CRS/no polyps
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score | 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. |
| Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score | 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. |
| Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score | 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. |
| Primary Outcome Measure 4: Baseline nasal cytokine concentration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score | 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. |
| Secondary Outcome Measure 2: Change from baseline to Month 3 in quality-of-life impact of olfactory dysfunction measured by QOD-NS score | 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. |
| Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score | 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. |
| Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration | 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. |
Countries
United States
Contacts
CONTACTJohn O'Neill
CONTACTChristopher Novicky
PRINCIPAL_INVESTIGATORMohamad Chaaban, MD
The Cleveland Clinic
Outcome results
None listed