Recruiting

Parosmia Investigation

Sponsor:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Code:

NCT07149428

Conditions

Respiratory Tract Infection

Smell Disorder

Influenza

Rhinosinusitis

COVID-19

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

Loss of the sense of smell can seriously affect a person's quality of life. The ability to smell can be damaged by many factors, including illnesses, injuries, and exposure to toxic chemicals. The effects can vary, including complete loss of smell, partial loss, and parosomia, which is when things smell differently than they should.

Objective:

To study how brain function changes in people with different types of smell disorders. Also, to look at how smell loss affects quality of life over time.

Eligibility:

People aged 18 years or older with a disorder that affects their sense of smell. Healthy volunteers are also needed.

Design:

Participants will have 5 study visits over 1 year. They will have various tests and procedures:

Smell tests. They will have several tests that involve smelling different items and answering questions.

Questionnaires. They will answer questions about their health, mood, sense of smell, and daily habits.

Magnetic resonance imaging (MRI) scans. They will lie on a bed that slides into a tube. Padding will hold their head still. They will smell different odors while in the scanner.

Electrobulbogram (EBG). They will wear a soft cap with sensors that measure brain activity. They will smell different odors while wearing the cap.

Nasal endoscopy. A flexible tube will be inserted into a nostril to view the inside of the nose.

Biopsy. A numbing substance will be sprayed into the nose. Then a scissor-like tool will be used to collect a sample of tissue from one or both nasal passages.

Samples of blood, urine, and nasal fluid will be taken.

Conditions

Respiratory Tract Infection

Smell Disorder

Influenza

Rhinosinusitis

COVID-19

Study ID

NCT07149428

Start date

Oct 1, 2026

Status verified date

Oct 7, 2026

Completion date

Oct 14, 2030

Anticipated

Primary completion date

Sep 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

To be eligible to participate in this study, an individual must meet all the following criteria:

1. Adult subjects, any sex, aged 18 or older.
2. Ability to understand and willingness to sign a written informed consent document.
3. Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study.
4. Due to the extensive questionnaires (administered in English language only) that participants must complete independently, fluency in the English language is needed. Hence, participants must be able to read and understand English.

\* To maintain consistency in the study, we will prioritize enrolling individuals who have experienced olfactory loss for no more than one year. However, the duration of olfactory dysfunction can vary significantly, often due to delayed awareness or recognition of the condition. For instance, anosmia and hyposmia are frequently reported as long-term consequences of infections, meaning some participants may have experienced prolonged dysfunction. Given this variability, we will treat the duration of olfactory loss as a potential confounding factor in our data analysis, ensuring that its influence is appropriately accounted for when interpreting the results. Other than healthy controls, participants reporting smell loss must also meet one or more of the following criteria to be eligible for the study:

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1. General Smell Loss:

Individuals who have experienced any degree of smell loss or olfactory dysfunction, regardless of the cause. This includes both partial, complete to distorted loss of the sense of smell (hyposmia, anosmia or parosmia).
2. Post-COVID-19 or Virus-Related Smell Loss:

Individuals experiencing olfactory dysfunction due to COVID-19, influenza or other respiratory viruses, leading to both acute and long-term (chronic) smell loss
3. Sinonasal Smell Loss:

Participants diagnosed with smell loss related to sinonasal conditions, such as:
  • Chronic Rhinosinusitis: Long-term inflammation of the sinuses that impairs olfactory function.
  • Nasal Polyps: Growths in the nasal passage that obstruct airflow and affect the sense of smell.
4. Exposure to Toxic Chemicals:

Patients who have encountered olfactory dysfunction due to exposure to harmful chemicals or environmental toxins that can impair the olfactory receptors or neural pathways responsible for the sense of smell.

5\. Chemotherapy-Induced Smell Loss:

Individuals who have experienced smell loss as a side effect of undergoing chemotherapy. This includes patients who are in active treatment as well as those who have completed chemotherapy but continue to suffer from olfactory impairment.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Compromised cognitive ability: Including dementia, intellectual disability, or severe learning disorders, traumatic brain injury,
2. Major psychotic and neurological condition: Examples include schizophrenia, bipolar disorder, Parkinson's disease, and multiple sclerosis, epilepsy.
3. Normosmia (healthy) controls must not have:

-Any history of smell or taste loss.

-Prior nasal surgery.
  • Acute or chronic olfactory disorders.
4. Diagnosis of depression or anxiety.
5. None of the participants should be current smokers or consume drugs such as cocaine, heroin, opioids, or marijuana.
6. Pregnancy

  • Participants who report moderate depressive symptoms (BDI >= 20) but do not have a formal diagnosis of depression will not be automatically excluded from the study. Instead, their responses will be flagged for clinical review and referral. If, upon follow-up, a clinical diagnosis of depression is confirmed, they may be excluded in accordance with the study's exclusion criteria. Participants who indicate any level of suicidality on question 9 will be evaluated on a case-by-case basis. If there is any indication of risk, they will be referred for immediate clinical evaluation. Depending on the outcome and the risk level determined, a decision will be made regarding their continued participation, with participant safety as the highest priority.

fMRI-Specific Exclusion Criteria

-Metallic implants, such as pacemakers, cochlear implants, or orthopedic devices, can pose safety risks during an MRI scan due to the strong magnetic fields used in the procedure. These implants can also cause artifacts in the MRI images, distorting the data and making it difficult to obtain accurate results.

  • Non-removable piercings can also cause safety risks and image artifacts during MRI scans. These piercings may heat up or move in response to the magnetic fields, potentially causing injury or discomfort to the participant.
  • Permanent makeup and tattoos, particularly those containing metallic pigments, can pose risks during MRI due to the potential for heating or movement of the pigments. These effects can cause discomfort or burns and will also create artifacts in the MRI images.
  • Pregnancy is an exclusion criterion for MRI studies due to the potential risks to the fetus from the strong magnetic fields and radiofrequency energy used in the procedure. Additionally, pregnant participants will find it uncomfortable to lie still in the MRI machine for extended periods, which could affect the quality of the images.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Anosmia

participants with complete loss of smell

Hyposmia

participants with reduced smell sensitivity

Normosmia (Healthy control cohort)

participants with normal smell function

Parosmia

participants with a distorted smell perception

Primary outcome measure

  • Functional Connectivity Differences in Olfactory Dysfunction [ Time Frame: baseline, 3, 6, 9 and 12 months ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

NIH Clinical Center Office of Patient Recruitment (OPR)

800-411-1222ccopr@nih.gov

More Information

Sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Last update posted

Oct 9, 2026

Last verified

Oct 7, 2026

Keywords

  • SMELL
  • Chemotherapy
  • chemicals
  • Mood
  • Diet
  • Neuroimaging
  • electrobulbogram
  • fMRI
  • Cognition
  • Toxins

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by National Institute on Deafness and Other Communication Disorders (NIDCD) on 2026-10-09. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.