Analysis of Human Olfactory Biopsies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Transcription state changes in olfactory cells
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1: Alzheimer's study
- •Inclusion Criteria:
- •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)
排除标准
- •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
- •Inclusion Criteria:
- •Age 18 years or older
- •Patients being seen for rhinology or olfactory disorders
- •Patients having unrelated endoscopic nasal surgery
- •Exclusion Criteria:
- •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
研究组 & 干预措施
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.
干预措施: olfactory testing (Diagnostic Test)
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.
干预措施: Odor stimulation (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.
干预措施: Olfactory biopsy (Procedure)
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.
干预措施: olfactory testing (Diagnostic Test)
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.
干预措施: Odor stimulation (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.
干预措施: Olfactory biopsy (Procedure)
结局指标
主要结局
Transcription state changes in olfactory cells
时间窗: study is planned for completion over 5 years
Using single cell RNA-sequencing, olfactory epithelial cell populations will be analyzed for changes in coherent gene expression programs from subjects in different environmental conditions.
次要结局
未报告次要终点