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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) | Active Comparator | Loss of smell + CRS with nasal polyps (CRSwNP) |
|
| Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training | Active Comparator | Loss of smell + CRS with nasal polyps (CRSwNP) - undergo 3 months of smell training |
|
| Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) | No Intervention | No loss of smell CRS with nasal polyps (CRSwNP) | |
| Control Group 2: -no loss of smell / no CRS/no polyps | No Intervention | No loss of smell / no CRS/no polyps |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smell Training | Other | Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John O'Neill | Contact | 4405062611 | ONEILLJ2@ccf.org | |
| Christopher Novicky | Contact | 216-444-7018 | novickc@ccf.org |
| Name | Affiliation | Role |
|---|---|---|
| Mohamad Chaaban, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D000086582 | Anosmia |
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000094562 | Olfactory Training |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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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
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| 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 | 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 | 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 | 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |