Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
Patients < 18 years of age
Individuals with unilateral nasal polyps
Autoimmune diseases
Ciliary disorders
Trial design
Design model
Parallel
Treatments tested in this trial
Smell Training
Other interventionPatients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
Treatment groups
52 Participants
are divided into 4 treatment groupsGroup A: Group 1: - loss of smell + CRS with nasal polyps (CRSwNP)Active comparator 1 intervention
Group B: Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell trainingActive comparator 1 intervention
Group C: Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)No intervention 0 interventions
Group D: Control Group 2: -no loss of smell / no CRS/no polypsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSecondary outcomes
1
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.
Time frame
Baseline to Month 32
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.
Time frame
Baseline to Month 33
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.
Time frame
Baseline to Month 34
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.
Time frame
Baseline to Month 3Sponsors and contacts
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Source ClinicalTrials.gov