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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study ID
NCT07149428
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Jun 16, 2026
Status verified
May 2026
Primary completion
Sep 30, 2029
Completion
Oct 14, 2029

Study Design

Enrollment
80 participants (estimated)

Arms

  • Arm: Anosmia
    participants with complete loss of smell
  • Arm: Hyposmia
    participants with reduced smell sensitivity
  • Arm: Normosmia (Healthy control cohort)
    participants with normal smell function
  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222
Anna Clements Centeno
[email protected]
(301) 451-1215

Find similar trials in Bethesda, MD

By condition
COVID-19 / long COVIDDepression
By specialty
Infectious diseasePsychiatryMental healthBehavioral health
By research site
National Institutes of Health Clinical Center· Bethesda, MD

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