Olfactory DysfunctionNCT07660887
Olfactory Dysfunction in Aging Adults
An observational study of Olfactory Dysfunction, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Olfactory Dysfunction
- What is being tested?
- Clinical and Biomarker Assessments
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2027to 30 Apr 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling adults aged 50 years and older recruited from the Medical University of South Carolina (MUSC) and surrounding community, including clinic patients and individuals responding to advertisements, who may have normal olfactory function or varying degrees of olfactory dysfunction.
Who may be able to join
- 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
Who cannot join
- Vulnerable populations including prisoners or institutionalized individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
MUSC
Charleston, South Carolina, 29425
Rodney Schlosser, MD, 8437927165, schlossr@musc.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Olfactory Dysfunction
- Being tested
- Clinical and Biomarker Assessments
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Biomarker AssessmentsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Older Adults With and Without Olfactory Dysfunction | Adults aged 50 years and older enrolled in a prospective cohort study assessing olfactory function, cognition, biomarkers, and quality of life, with annual follow-up. Participants will be classified post hoc into olfactory phenotypes based on testing results. Receives: Other: Clinical and Biomarker Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory Function
Olfactory Threshold, Discrimination, and Identification (TDI scores) using Sniffin' Sticks.
Measured: Baseline
Secondary outcomes (2)
Change in Olfactory Function Over Time
Longitudinal assessment of changes in olfactory function to identify decline over time.. Change in TDI scores (threshold, discrimination, identification)
Measured: Year 1 and year 2
Patient-Reported Outcomes
Patient-reported measure assessing quality of life using QOD questionnaire.
Measured: Baseline, Year 1 and year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Apr 2027 (estimated)
- Primary completion30 Apr 2032 (estimated)
- Study completion30 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Olfactory DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660887
- Sponsor's protocol ID
- Pro00150356
- Other IDs
- 5R01DC019078-05
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Protection of individual privacy
Publications
Soler ZM, Gregoski MJ, Kohli P, LaPointe KA, Schlosser RJ. Development and validation of the four-item Concise Aging adults Smell Test to screen for olfactory dysfunction in older adults. Int Forum Allergy Rhinol. 2025 Mar;15(3):250-257. doi: 10.1002/alr.23476. Epub 2024 Oct 27.
PubMed 39462307
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olfactory Dysfunction in Aging Adults
- ClinicalTrials.gov ID
- NCT07660887
- Acronym / sponsor ID
- Pro00150356
- Conditions
- Olfactory Dysfunction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 1 Apr 2027 (estimated)
- Primary completion
- 30 Apr 2032 (estimated)
- Study completion
- 30 Apr 2032 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older Adults With and Without Olfactory Dysfunction | – | Other: Clinical and Biomarker AssessmentsAdults aged 50 years and older enrolled in a prospective cohort study assessing olfactory function, cognition, biomarkers, and quality of life, with annual follow-up. Participants will be classified post hoc into olfactory phenotypes based on testing results. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling adults aged 50 years and older recruited from the Medical University of South Carolina (MUSC) and surrounding community, including clinic patients and individuals responding to advertisements, who may have normal olfactory function or varying degrees of olfactory dysfunction.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Vulnerable populations including prisoners or institutionalized individuals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Biomarker AssessmentsParticipants 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. | Other | Older Adults With and Without Olfactory Dysfunction |
Primary outcome
Olfactory Function
Time frame: Baseline
Olfactory Threshold, Discrimination, and Identification (TDI scores) using Sniffin' Sticks.
2 secondary outcomes
Change in Olfactory Function Over Time
Time frame: Year 1 and year 2
Patient-Reported Outcomes
Time frame: Baseline, Year 1 and year 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 39462307Soler ZM, Gregoski MJ, Kohli P, LaPointe KA, Schlosser RJ. Development and validation of the four-item Concise Aging adults Smell Test to screen for olfactory dysfunction in older adults. Int Forum Allergy Rhinol. 2025 Mar;15(3):250-257. doi: 10.1002/alr.23476. Epub 2024 Oct 27.
- Individual participant dataSharing planned: No. Protection of individual privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Olfactory Dysfunction, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodney Schlosser, MD (18437927165, schlossr@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory Function (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07660887, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.