Olfactory Biopsies

Официальное название

Analysis of Human Olfactory Biopsies

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.
• Другое 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.
• Процедура 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

Первичные конечные точки

• Transcription state changes in olfactory cells [Срок оценки: study is planned for completion over 5 years]

Критерии участия

Group 1: Alzheimer's study

Критерии включения

• Between the ages of 18 and 80
• Pre-clinical AD (this cohort consists of subjects who have normal cognitive testing and function, but have positive AD biomarkers);
• Symptomatic AD (a confirmed diagnosis of Alzheimer's or dementia who are capable of understanding and signing the consent document)

Критерии исключения

• Advanced Alzheimer's/dementia
• Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)
• Active Rhinosinusitis symptoms
• Other known sinonasal disease history that would preclude biopsy (i.e prior sinus or skull base surgery directly impacting this anatomic region, sinonasal neoplasm in this anatomic region, olfactory cleft polyps)
• Parkinson's disease
• Unable or willing to complete the nasal endoscopy procedure.
• Unable to read or speak English
• Unable to provide legally effective consent

Group 2: Act-seq study or Non-AD controls

Критерии включения

• Age 18 years or older
• Patients being seen for rhinology or olfactory disorders
• Patients having unrelated endoscopic nasal surgery

Критерии исключения

• Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)
• Unable or willing to complete the nasal endoscopy procedure
• Unable to read or speak English
• Unable to provide legally effective consent

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Duke University Health Center — Durham

Идентификаторы

NCT: NCT07021040 · Pro00116591 · 1R01DC021422-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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