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

26. juni 2026 oppdatert av: The Cleveland Clinic

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Christopher Novicky
  • Telefonnummer: 216-444-7018
  • E-post: novickc@ccf.org

Studiesteder

  • Forente stater
    • Ohio
      • Cleveland, Ohio, Forente stater, 44195
        • Rekruttering
        • The Cleveland Clinic
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mohamad Chaaban

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Group 1: - loss of smell + CRS with nasal polyps (CRSwNP)
Loss of smell + CRS with nasal polyps (CRSwNP)
Annen: Smell Training
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
Aktiv komparator: 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
Annen: Smell Training
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
Ingen inngripen: Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP)
No loss of smell CRS with nasal polyps (CRSwNP)
Ingen inngripen: Control Group 2: -no loss of smell / no CRS/no polyps
No loss of smell / no CRS/no polyps

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
Tidsramme: 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.
Baseline
Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score
Tidsramme: 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.
Baseline
Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score
Tidsramme: 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.
Baseline
Primary Outcome Measure 4: Baseline nasal cytokine concentration
Tidsramme: 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.
Baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
Tidsramme: 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.
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
Tidsramme: 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.
Baseline to Month 3
Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score
Tidsramme: 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.
Baseline to Month 3
Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration
Tidsramme: 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.
Baseline to Month 3

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

The Cleveland Clinic

Etterforskere

  • Hovedetterforsker: Mohamad Chaaban, MD, The Cleveland Clinic

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. desember 2025

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. mars 2027

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

26. juni 2026

Først lagt ut (Faktiske)

2. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB #24-1122

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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