NCT07021040

Olfactory Biopsies

Analysis of Human Olfactory Biopsies

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This research study aims to investigate the function of the olfactory lining in the nasal cavity and its potential alterations in both healthy and diseased conditions. The olfactory lining is involved in the sense of smell. The purpose of this study is to collect tissue from the nasal cavity.

Detailed description

The purpose of this study is to analyze cell populations active in human olfactory tissue in health and disease. This is a prospective study. Healthy participants or participants with known disease processes that may impact olfaction, such as Alzheimer's, inflammatory conditions, aging, or post-viral smell loss, will be included. Olfaction will be measured using standard psychophysical testing. Biopsies of the olfactory lining in the nasal cavity may be obtained in the otolaryngology clinic or the operating room, if the patient is having an unrelated endoscopic nasal surgery, and may be obtained using a punch technique or a cytology brush. Before biopsies, some patients may be asked to sniff an odor substance (such as lavender, mint, citrus, or cloves) briefly, to stimulate olfactory cells. Biopsies will be processed for assays in the PI's lab, including histology, primary culture assays, flow cytometry assays, or transcriptomic profiling.

Conditions

• Alzheimer Disease
• Smell Loss
• Smell Dysfunction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-06
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-06-13
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States