NOT_YET_RECRUITING

Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Longitudinal Deep Phenotyping of Central Mechanisms in Dysosmia: A Pilot Study Using Electrobulbogram (EBG), Functional MRI (fMRI), and Diffusion-Weighted Imaging (DWI)

Quick Facts

Study Start:2026-01-27
Study Completion:2029-10-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:NOT_YET_RECRUITING

Study ID

NCT07149428

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult subjects, any sex, aged 18 or older.
  2. 2. Ability to understand and willingness to sign a written informed consent document.
  3. 3. Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study.
  4. 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.
  5. 1. General Smell Loss:
  6. 2. Post-COVID-19 or Virus-Related Smell Loss:
  7. 3. Sinonasal Smell Loss:
  8. * Chronic Rhinosinusitis: Long-term inflammation of the sinuses that impairs olfactory function.
  9. * Nasal Polyps: Growths in the nasal passage that obstruct airflow and affect the sense of smell.
  10. 4. Exposure to Toxic Chemicals:
  1. 1. Compromised cognitive ability: Including dementia, intellectual disability, or severe learning disorders, traumatic brain injury,
  2. 2. Major psychotic and neurological condition: Examples include schizophrenia, bipolar disorder, Parkinson's disease, and multiple sclerosis, epilepsy.
  3. 3. Normosmia (healthy) controls must not have:
  4. * Acute or chronic olfactory disorders.
  5. 4. Diagnosis of depression or anxiety.
  6. 5. None of the participants should be current smokers or consume drugs such as cocaine, heroin, opioids, or marijuana.
  7. 6. Pregnancy
  8. * 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.
  9. * 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.
  10. * 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.
  11. * 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.

Contacts and Locations

Study Contact

Anna E Clements Centeno
CONTACT
(301) 451-1215
anna.clements@nih.gov
Joshua M Levy, M.D.
CONTACT
(240) 935-8305
joshua.levy@nih.gov

Principal Investigator

Joshua M Levy, M.D.
PRINCIPAL_INVESTIGATOR
National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Institute on Deafness and Other Communication Disorders (NIDCD)

  • Joshua M Levy, M.D., PRINCIPAL_INVESTIGATOR, National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2026-01-27
Study Completion Date2029-10-14

Study Record Updates

Study Start Date2026-01-27
Study Completion Date2029-10-14

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Respiratory Tract Infection
  • Smell Disorder
  • Influenza
  • Rhinosinusitis
  • COVID-19
  • Depression
  • Parosmia
  • Hyposomia
  • Normosomia
  • Anosmia