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NCT Number: NCT07660887

Olfactory Dysfunction in Aging Adults

This prospective longitudinal cohort study will enroll adults aged 50 years and older to characterize olfactory dysfunction in aging. Participants will undergo comprehensive olfactory testing, cognitive assessment, biomarker collection, and imaging to identify clinically relevant phenotypes based on anatomic site of dysfunction. The study will also evaluate the impact of olfactory dysfunction on quality of life and identify baseline factors associated with changes in olfactory function over time.

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Key information

Conditions

Olfactory Dysfunction

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

Olfactory dysfunction is common in older adults and is associated with impaired quality of life and increased mortality, yet underlying mechanisms and clinically relevant classifications remain poorly defined. Prior studies have relied on limited screening methods and have not adequately characterized the anatomic sites or mechanisms contributing to olfactory loss.

This prospective longitudinal cohort study will enroll adults aged 50 years and older to comprehensively evaluate olfactory function and its determinants. Participants will undergo psychophysical olfactory testing using Sniffin' Sticks (threshold, discrimination, and identification), cognitive assessment, nasal endoscopy, and olfactory mucus collection for biomarker analysis. A subset of participants will also undergo magnetic resonance imaging to assess peripheral and central olfactory structures.

The primary objective is to establish clinically relevant phenotypes of olfactory dysfunction based on olfactory testing and cognitive function, corresponding to peripheral, sensorineural, or central mechanisms. Secondary objectives are to determine the impact of olfactory dysfunction on quality of life, depression, social isolation, and nutrition using validated patient-reported outcome measures, and to identify baseline factors that predict longitudinal changes in olfactory function.

Participants will be followed annually with repeat olfactory testing and outcome assessments to evaluate changes over time and identify predictors of olfactory decline. This study aims to improve understanding of olfactory dysfunction in aging and provide a foundation for future diagnostic and therapeutic strategies.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 50 years or older
  • Ability to follow instructions and understand consent process in English
  • Adequate visual, auditory, or motor functioning to complete items in the test battery or availability of assistance or assist devices to complete tasks

Exclusion criteria

  • Vulnerable populations including prisoners or institutionalized individuals

Treatment and study plan

Clinical and Biomarker Assessments

Other

Participants undergo olfactory testing (Sniffin' Sticks), cognitive assessment, nasal endoscopy, olfactory mucus collection, MRI imaging (subset), and patient-reported outcome measures to evaluate olfactory function, biomarkers, and health outcomes over time.

Primary outcomes

  1. Olfactory Function

    Time frame: Baseline

    Olfactory Threshold, Discrimination, and Identification (TDI scores) using Sniffin' Sticks.

Secondary outcomes

  1. Change in Olfactory Function Over Time

    Time frame: Year 1 and year 2

    Longitudinal assessment of changes in olfactory function to identify decline over time.. Change in TDI scores (threshold, discrimination, identification)

  2. Patient-Reported Outcomes

    Time frame: Baseline, Year 1 and year 2

    Patient-reported measure assessing quality of life using QOD questionnaire.

Study contacts

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

Rodney Schlosser, MD

CONTACT

[email protected]

18437927165

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2027
Primary completion
2032
Study completion
2032
First posted
Jun 22, 2026
Registry last updated
Jun 22, 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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