Olfactory Biopsies

NARecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2028

Conditions
Alzheimer DiseaseSmell LossSmell Dysfunction
Interventions
DIAGNOSTIC_TEST

olfactory testing

"Patients will undergo smell testing, using the Smell Identification Test (Sensonics), a validated widely-used 40-item scratch-and-sniff style psychophysical test to determine olfactory function."

OTHER

Odor stimulation

"subset of patients will be asked to sniff a specific odor for about an hour, using commercially available odor pens (Sniffin' Sticks or Sensonics). These odor pens are widely used for olfactory training therapy, a treatment designed to help people with some forms of smell loss; they are also used in psychophysical olfactory testing."

PROCEDURE

Olfactory biopsy

Biopsy involves a simple cytology brush technique of the lining of the nose in a region called the olfactory cleft, using a nasal endoscope, and can be done in clinic or in the operating room at the time of a nasal surgery. Topical oxymetazoline and tetracaine spray is applied to the nasal cavity, a rigid nasal endoscopy (0-degree 4 mm endoscope, Karl Storz) is performed to visualize the olfactory cleft, and a small nasal cytology brush biopsy (Hobbs Medical)is performed by swabbing and rotating brush gently in the olfactory cleft. Cytology sample is placed into a buffer (Hibernate-E, Thermo Fisher)on ice for transport to the research lab.

Trial Locations (1)

27710

RECRUITING

Duke University Health Center, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

lead

Duke University

OTHER

NCT07021040 - Olfactory Biopsies | Biotech Hunter | Biotech Hunter