Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training

NCT07681973 | Recruiting

• 1 other identifier: IRB #24-1122
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Smell Loss; Chronic Rhinosinusitis (CRS)

Keywords

Smell Loss; Chronic Rhinosinusitis; Nasal Polyps; CRSwNP

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

• Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score

  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

  Baseline to Month 3

• Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score

  Baseline to Month 3

• Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration

  Baseline to Month 3

Study Arms (4)

Group 1: - loss of smell + CRS with nasal polyps (CRSwNP)

ACTIVE COMPARATOR

Loss of smell + CRS with nasal polyps (CRSwNP)

Other: Smell Training

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

Other: 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

Interventions

Smell Training OTHER

Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.

Group 1: - loss of smell + CRS with nasal polyps (CRSwNP); Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Patients \< 18 years of age
• Individuals with unilateral nasal polyps
• Autoimmune diseases
• Ciliary disorders
• Cystic fibrosis
• Smell loss due to tumors or trauma

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Anosmia; Nasal Polyps

Interventions

Olfactory Training

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Mohamad Chaaban, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John O'Neill

CONTACT

4405062611; ONEILLJ2@ccf.org

Christopher Novicky

CONTACT

216-444-7018; novickc@ccf.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: July 2, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)