Olfactory Biopsies

Conditions

• Alzheimer Disease
• Smell Dysfunction
• Smell Loss

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• olfactory testing — DIAGNOSTIC_TEST
  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.
• Odor stimulation — OTHER
  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.
• Olfactory biopsy — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Jan 6, 2025

Status verified

Jun 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2028

Study Design

Enrollment

125 participants (estimated)

Allocation

NA

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Arms

• Other: Alzheimer's study
  Olfactory function will be assessed using the Smell Identification Test (SIT, Sensonics, Inc) or Sniffin' Sticks Test. Using topical intranasal decongestion/anesthetic (oxymetazoline/lidocaine), a cytology brush biopsy will be obtained from the olfactory cleft region of the nose in clinic exam room using a nasal endoscope.
• Other: Act-seq study or Non-AD controls
  Olfactory function will be measured using established psychophysical testing via the Smell Identification Test or Sniffin' Sticks. Researchers will obtain biopsies from (1) normosmic subjects with or without odor stimulation, and (2) hyposmic subjects with history of upper respiratory infection (URI) as likely cause of the smell loss (such as COVID19) with or without odor stimulation.

Primary Outcome Measure

Transcription state changes in olfactory cells [ Time Frame: study is planned for completion over 5 years ]

Central Contacts

• Maria J Manson, MBA
  (919) 684-0525
  [email protected]
• Bradley J Goldstein, MD, PhD
  (919) 684 3834
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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