Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training
Purpose
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.
Conditions
- Smell Loss
- Chronic Rhinosinusitis (CRS)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- 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
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) |
Loss of smell + CRS with nasal polyps (CRSwNP) |
|
|
Active Comparator 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 |
|
|
No Intervention Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) |
No loss of smell CRS with nasal polyps (CRSwNP) |
|
|
No Intervention Control Group 2: -no loss of smell / no CRS/no polyps |
No loss of smell / no CRS/no polyps |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- The Cleveland Clinic
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.