Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Smell Training.
- Who it may be relevant to
- Registry conditions: Smell Loss, Chronic Rhinosinusitis (CRS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Smell Training
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
Primary outcome measures
- Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score [Time frame: Baseline]
- Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score [Time frame: Baseline]
- Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score [Time frame: Baseline]
- Primary Outcome Measure 4: Baseline nasal cytokine concentration [Time frame: Baseline]
Secondary outcome measures (4)
- Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score [Time frame: 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 [Time frame: Baseline to Month 3]
- Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score [Time frame: Baseline to Month 3]
- Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration [Time frame: Baseline to Month 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 1 center
- The Cleveland Clinic — Cleveland
Identifiers
NCT: NCT07681973 · IRB #24-1122