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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorNational Institute on Deafness and Other Communication Disorders (NIDCD)

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult subjects, any sex, aged 18 or older.

Ability to understand and willingness to sign a written informed consent document.

Willingness and ability to comply with and participate in all study procedures and availability for the duration of the study.

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.

Disqualifiers

Compromised cognitive ability: Including dementia, intellectual disability, or severe learning disorders, traumatic brain injury,

Major psychotic and neurological condition: Examples include schizophrenia, bipolar disorder, Parkinson's disease, and multiple sclerosis, epilepsy.

Acute or chronic olfactory disorders.

Diagnosis of depression or anxiety.

Trial population

The study will enroll adults aged 18 and older who are fluent in English and able to provide informed consent and comply with study procedures. Participants will include both healthy volunteers with normal smell and individuals with olfactory dysfunction of varying causes, such as post viral (including COVID-19), sinonasal disease, chemical exposure, or chemotherapy-related smell loss. To maintain consistency, preference will be given to participants who have experienced smell loss within the past year, through those with longer durations of dysfunction may be included.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 4 trial groups
Group A: Anosmia
Group B: Hyposmia
Group C: Normosmia (Healthy control cohort)
Group D: Parosmia

Trial outcomes

Primary outcomes

1

Functional Connectivity Differences in Olfactory Dysfunction

differences in functional brain connectivity between parosmia, anosmia and hyposmia groups, assessed longitudinally.

Time frame
baseline, 3, 6, 9 and 12 months

Secondary outcomes

1

Structural Brain Changes in Olfactory Dysfunction

Structural brain architecture differences in olfactory-related regions, measured with neuroimaging.

Time frame
baseline, 3, 6, 9 and 12 months
2

Cognitive, Mood and Dietary Impact of Olfactory Dysfunction

Associations between olfactory function and changes in cognition, depressive symptoms and dietary habits, evaluated through surveys and behavioral measures.

Time frame
baseline, 3, 6, 9 and 12 months

Other outcomes

Sponsors and contacts

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