Smell LossCIPODNCT07681973
Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training
A study testing Smell Training in people with Smell Loss and Chronic Rhinosinusitis (CRS), run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smell Loss, Chronic Rhinosinusitis (CRS)
- What is being tested?
- Smell Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2025to 31 Mar 2027
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Patients < 18 years of age
- Individuals with unilateral nasal polyps
- Autoimmune diseases
- Ciliary disorders
- Cystic fibrosis
- Smell loss due to tumors or trauma
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, 1 recruiting
- Recruiting
The Cleveland Clinic
Cleveland, Ohio, 44195
John O'Neill, 4405062611, ONEILLJ2@ccf.org
Hana Rosen, 216-444-7018, rosenh@ccf.org
About this study
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.
Read the detailed description
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.
- Conditions
- Smell Loss, Chronic Rhinosinusitis (CRS)
- Being tested
- Smell Training
- Keywords
- Smell Loss, Chronic Rhinosinusitis, Nasal Polyps, CRSwNP
- Medical subject headings
- Anosmia, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smell TrainingOther
Patients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) | Active comparator | Loss of smell + CRS with nasal polyps (CRSwNP) Receives: Other: Smell Training |
| Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training | Active comparator | Loss of smell + CRS with nasal polyps (CRSwNP) - undergo 3 months of smell training Receives: Other: Smell Training |
| Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) | No intervention | No loss of smell CRS with nasal polyps (CRSwNP) |
| Control Group 2: -no loss of smell / no CRS/no polyps | No intervention | No loss of smell / no CRS/no polyps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
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.
Measured: Baseline
Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score
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.
Measured: Baseline
Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score
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.
Measured: Baseline
Primary Outcome Measure 4: Baseline nasal cytokine concentration
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.
Measured: Baseline
Secondary outcomes (4)
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
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.
Measured: 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
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.
Measured: Baseline to Month 3
Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score
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.
Measured: Baseline to Month 3
Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration
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.
Measured: Baseline to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start9 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smell LossStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of 4 Groups Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) Group 2: - loss of smell with no CRS/no polyps Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) Control Group 2: -no loss of smell / no CRS/no polyps
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad Chaaban, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07681973
- Sponsor's protocol ID
- IRB #24-1122
- Acronym
- CIPOD
- Status last verified
- Jun 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training
- ClinicalTrials.gov ID
- NCT07681973
- Acronym / sponsor ID
- CIPOD / IRB #24-1122
- Conditions
- Smell Loss, Chronic Rhinosinusitis (CRS)
- Keywords
- Smell Loss, Chronic Rhinosinusitis, Nasal Polyps, CRSwNP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Jul 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A total of 4 Groups Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) Group 2: - loss of smell with no CRS/no polyps Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) Control Group 2: -no loss of smell / no CRS/no polyps
| Arm | Type | Receives |
|---|---|---|
| Group 1: - loss of smell + CRS with nasal polyps (CRSwNP) | Active comparator | Other: Smell TrainingLoss of smell + CRS with nasal polyps (CRSwNP) |
| Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training | Active comparator | Other: Smell TrainingLoss of smell + CRS with nasal polyps (CRSwNP) - undergo 3 months of smell training |
| Control Group 1: - no loss of smell CRS with nasal polyps (CRSwNP) | No intervention | –No loss of smell CRS with nasal polyps (CRSwNP) |
| Control Group 2: -no loss of smell / no CRS/no polyps | No intervention | –No loss of smell / no CRS/no polyps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- Patients < 18 years of age
- Individuals with unilateral nasal polyps
- Autoimmune diseases
- Ciliary disorders
- Cystic fibrosis
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 |
|---|---|---|
| Smell TrainingPatients experiencing loss of smell from chronic rhinosinusitis (CRS)will undergo smell training. | Other | Group 1: - loss of smell + CRS with nasal polyps (CRSwNP), Group 2: - loss of smell with no CRS/no polyps - undergo 3 months of smell training |
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score
Time frame: 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
Time frame: Baseline to Month 3
Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score
Time frame: Baseline to Month 3
Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration
Time frame: Baseline to Month 3
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 2 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Mohamad Chaaban, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smell Training in people with Smell Loss and Chronic Rhinosinusitis (CRS), run by The Cleveland Clinic 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 6 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 2 Jul 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 John O'Neill (4405062611, ONEILLJ2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score (time frame: Baseline). The study lists 4 primary outcomes in all. 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 2 Jul 2026.