Olfactory DysfunctionPhase 2NCT07222891
Impact of Smell Testing on Health Outcomes
A Phase 2 study testing Patient-centered information and education in people with Olfactory Dysfunction and Wellbeing, run by Monell Chemical Senses Center at 1 site in United States.
Trial summary
Smell dysfunction is frequent yet neglected. The sense of smell plays a crucial role in signaling disease, safety, and overall quality of life. However, the significance of a functional sense of smell in terms of health and well-being is often overlooked until one experiences a loss of smell due to injury or disease. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Olfactory Dysfunction, Wellbeing
- What is being tested?
- Patient-centered information and education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2026to 30 Nov 2027
- Phase
- Phase 2
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Can read and understand English and have access to a reliable internet connection and a smart device or computer for the duration of the experimental sessions, unless they are part of community events in which smart devices are provided
Who cannot join
- Known intolerance or allergy to any of the odor stimuli used
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pamela Dalton contact
United States1 site, 1 recruiting
- Recruiting
Monell Chemical Senses Center
Philadelphia, Pennsylvania, 19104
Ryann Kolb, 267-519-4681, rkolb@monell.org
Valentina Parma, vparma@monell.org
About this study
Official title: Validating the Impact of Smell Testing on Health Outcomes and Provider Engagement.
Smell dysfunction is frequent yet neglected. The sense of smell plays a crucial role in signaling disease, safety, and overall quality of life. However, the significance of a functional sense of smell in terms of health and well-being is often overlooked until one experiences a loss of smell due to injury or disease. Research demonstrates that individuals are often not self-aware of their smell dysfunction (i.e. they do not spontaneously report smell dysfunction as a symptom), especially if the changes are gradual, as in normal aging. Patients with smell dysfunction experience a marked reduction in quality of life, poor mental health, nutritional health, and brain health as well as increased 5- and 10-year mortality in older adults. This study explores whether or not enabling healthcare providers to offer resources and guidance on coping strategies for smell dysfunction improves health and wellbeing in those who experience it.
Read the detailed description
The investigators will recruit participants in cycles for in person or remote participation. Each cycle is characterized by an initial assessment, intervention deployment (smell testing), post-intervention evaluation, 1-month and 6-month follow-ups via survey, text or phone to assess post-intervention psychological health and connection to care for smell dysfunction. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-offs determined prior to the beginning of data collection, the investigators will prospectively assign a participant to the smell dysfunction group or to the normosmia (no smell dysfunction) group. Based on this diagnostic intervention, participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support. At the end of the 1-month and 6-month follow-up periods, the investigators will assess effectiveness of the intervention using pre-post comparisons to determine whether individuals taking a smell test felt improvements in their psychological health and whether they have contacted a provider and/or followed up with a visit.
Sessions may include multiple surveys/instruments depending on the session number. Specifically, emotional ratings and demographic information will be collected by means of either a paper - or computer-based questionnaire. A survey to measure psychological health and quality of life will be given to participants, as well as a questionnaire to measure depression, which is associated with smell dysfunction. Participants will answer questions about how they are feeling and how ready they are to contact a healthcare provider. The specific smell tests that will be given to participants will be either SCENTinel, NIH Toolbox, Arohma, or the B-SIT test. Other Follow-Up Questions include ones regarding access to care, contacting a provider, seeing a provider, and satisfaction with care.
- Conditions
- Olfactory Dysfunction, Wellbeing
- Being tested
- Patient-centered information and education
- Keywords
- Olfactory testing, Smell dysfunction, Psychological health, Randomized clinical trial, Patient-centered care, Access to care
- Medical subject headings
- Olfaction Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered information and educationBehavioural
Participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support.
| Study group | Role | What they receive |
|---|---|---|
| Smell dysfunction detection and educational intervention | Experimental | Participants will take smell tests and receive educational materials on smell dysfunction. Receives: Behavioral: Patient-centered information and education |
| Normosmia | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring depression symptoms using the PHQ-9 score
The PHQ-9 is a screening measure of depressive symptoms.
Measured: PHQ-9 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Secondary outcomes (3)
Measuring health-related quality of life using the SF-12 survey.
The SF-12 is a screening measure of health-related quality of life.
Measured: SF-12 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Measuring self-reported health perception using a "How do you feel?" 0-100 Visual Analogue Scale (VAS).
"How do you feel?" VAS is a self-reported measure of health perception.
Measured: VAS is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Effectiveness of implementation (to contact a healthcare provider for smell dysfunction within up to 6 months from smell testing).
Participants are asked a Yes or No question about whether they contacted a healthcare provider. The investigators will examine the proportion of participants connecting with a healthcare provider for smell dysfunction.
Measured: Evaluated during 1 month and 6 month follow ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2025
- Study start29 May 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Olfactory data will be collected with six standardized smell tests in the in-person cohort and four standardized smell tests in the remote cohort. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-off scores determined before the beginning of data collection, the investigators will assign a participant to the smell dysfunction group or to the normosmia (non-smell dysfunction) group. Based on this diagnostic intervention, participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monell Chemical Senses Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, Valentina Parma, Monell Chemical Senses Center
- Investigators
- Valentina Parma, Principal investigator, Monell Chemical Senses CenterPamela Dalton, Principal investigator, Monell Chemical Senses CenterDanielle Reed, Principal investigator, Monell Chemical Senses Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222891
- Sponsor's protocol ID
- 856831
- Other IDs
- R44DC022498
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating the Impact of Smell Testing on Health Outcomes and Provider Engagement.
- ClinicalTrials.gov ID
- NCT07222891
- Acronym / sponsor ID
- 856831
- Conditions
- Olfactory Dysfunction, Wellbeing
- Keywords
- Olfactory testing, Smell dysfunction, Psychological health, Randomized clinical trial, Patient-centered care, Access to care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Monell Chemical Senses CenterUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 29 May 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 30 Oct 2025 (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.
Smell dysfunction is frequent yet neglected. The sense of smell plays a crucial role in signaling disease, safety, and overall quality of life. However, the significance of a functional sense of smell in terms of health and well-being is often overlooked until one experiences a loss of smell due to injury or disease. Research demonstrates that individuals are often not self-aware of their smell dysfunction (i.e. they do not spontaneously report smell dysfunction as a symptom), especially if the changes are gradual, as in normal aging. Patients with smell dysfunction experience a marked reduction in quality of life, poor mental health, nutritional health, and brain health as well as increased 5- and 10-year mortality in older adults. This study explores whether or not enabling healthcare providers to offer resources and guidance on coping strategies for smell dysfunction improves health and wellbeing in those who experience it.
Detailed description
The investigators will recruit participants in cycles for in person or remote participation. Each cycle is characterized by an initial assessment, intervention deployment (smell testing), post-intervention evaluation, 1-month and 6-month follow-ups via survey, text or phone to assess post-intervention psychological health and connection to care for smell dysfunction. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-offs determined prior to the beginning of data collection, the investigators will prospectively assign a participant to the smell dysfunction group or to the normosmia (no smell dysfunction) group. Based on this diagnostic intervention, participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support. At the end of the 1-month and 6-month follow-up periods, the investigators will assess effectiveness of the intervention using pre-post comparisons to determine whether individuals taking a smell test felt improvements in their psychological health and whether they have contacted a provider and/or followed up with a visit.
Sessions may include multiple surveys/instruments depending on the session number. Specifically, emotional ratings and demographic information will be collected by means of either a paper - or computer-based questionnaire. A survey to measure psychological health and quality of life will be given to participants, as well as a questionnaire to measure depression, which is associated with smell dysfunction. Participants will answer questions about how they are feeling and how ready they are to contact a healthcare provider. The specific smell tests that will be given to participants will be either SCENTinel, NIH Toolbox, Arohma, or the B-SIT test. Other Follow-Up Questions include ones regarding access to care, contacting a provider, seeing a provider, and satisfaction with care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Olfactory data will be collected with six standardized smell tests in the in-person cohort and four standardized smell tests in the remote cohort. The research team will assess odor detection, intensity, identification, pleasantness and discrimination. Based on the cut-off scores determined before the beginning of data collection, the investigators will assign a participant to the smell dysfunction group or to the normosmia (non-smell dysfunction) group. Based on this diagnostic intervention, participants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support.
| Arm | Type | Receives |
|---|---|---|
| Smell dysfunction detection and educational intervention | Experimental | Behavioral: Patient-centered information and educationParticipants will take smell tests and receive educational materials on smell dysfunction. |
| Normosmia | No intervention | –No intervention |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Can read and understand English and have access to a reliable internet connection and a smart device or computer for the duration of the experimental sessions, unless they are part of community events in which smart devices are provided
Key exclusion criteria (1 listed)
- Known intolerance or allergy to any of the odor stimuli used
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 |
|---|---|---|
| Patient-centered information and educationParticipants with smell dysfunction will receive patient-centered information and education about i) community engagement with individuals with smell loss, ii) available counseling and iii) medical support. | Behavioural | Smell dysfunction detection and educational intervention |
Primary outcome
Measuring depression symptoms using the PHQ-9 score
Time frame: PHQ-9 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
The PHQ-9 is a screening measure of depressive symptoms.
3 secondary outcomes
Measuring health-related quality of life using the SF-12 survey.
Time frame: SF-12 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Measuring self-reported health perception using a "How do you feel?" 0-100 Visual Analogue Scale (VAS).
Time frame: VAS is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.
Effectiveness of implementation (to contact a healthcare provider for smell dysfunction within up to 6 months from smell testing).
Time frame: Evaluated during 1 month and 6 month follow ups
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 6 Oct 2026.
- Individual participant dataSharing planned: Yes. All collected data
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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.
Pamela Dalton contact
Valentina Parma principal investigator
Monell Chemical Senses Center
Pamela Dalton principal investigator
Monell Chemical Senses Center
Danielle Reed principal investigator
Monell Chemical Senses Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patient-centered information and education in people with Olfactory Dysfunction and Wellbeing, run by Monell Chemical Senses Center 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 1 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: looking for participants now, as of the sponsor's last update on 6 Oct 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Valentina Parma (+1 (267) 519 - 4680, vparma@monell.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring depression symptoms using the PHQ-9 score (time frame: PHQ-9 is completed at baseline, during 1 month follow-up session, and during the 6 month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.