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NCT Number: NCT07681973

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

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.

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Key information

Conditions

Smell Loss Anosmia Chronic Rhinosinusitis (CRS) Nasal Polyps Nervous System Diseases Neurologic Manifestations Nose Diseases Olfaction Disorders Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smell training

Other

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

Primary outcomes

  1. Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score

    Time frame: Baseline

    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.

  2. Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score

    Time frame: Baseline

    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.

  3. Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score

    Time frame: Baseline

    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.

  4. Primary Outcome Measure 4: Baseline nasal cytokine concentration

    Time frame: Baseline

    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.

Secondary outcomes

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

    Time frame: Baseline to Month 3

    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.

  2. 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

    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.

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

    Time frame: Baseline to Month 3

    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.

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

    Time frame: Baseline to Month 3

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christopher Novicky

CONTACT

[email protected]

216-444-7018

John O'Neill

CONTACT

[email protected]

4405062611

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: CIPOD

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 2, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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