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临床试验/NCT07660887
NCT07660887尚未招募不适用

Olfactory Dysfunction in Aging Adults

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2027年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
Olfactory Function

研究概览

简要总结

This prospective longitudinal cohort study will enroll adults aged 50 years and older to characterize olfactory dysfunction in aging. Participants will undergo comprehensive olfactory testing, cognitive assessment, biomarker collection, and imaging to identify clinically relevant phenotypes based on anatomic site of dysfunction. The study will also evaluate the impact of olfactory dysfunction on quality of life and identify baseline factors associated with changes in olfactory function over time.

详细描述

Olfactory dysfunction is common in older adults and is associated with impaired quality of life and increased mortality, yet underlying mechanisms and clinically relevant classifications remain poorly defined. Prior studies have relied on limited screening methods and have not adequately characterized the anatomic sites or mechanisms contributing to olfactory loss.

This prospective longitudinal cohort study will enroll adults aged 50 years and older to comprehensively evaluate olfactory function and its determinants. Participants will undergo psychophysical olfactory testing using Sniffin' Sticks (threshold, discrimination, and identification), cognitive assessment, nasal endoscopy, and olfactory mucus collection for biomarker analysis. A subset of participants will also undergo magnetic resonance imaging to assess peripheral and central olfactory structures.

The primary objective is to establish clinically relevant phenotypes of olfactory dysfunction based on olfactory testing and cognitive function, corresponding to peripheral, sensorineural, or central mechanisms. Secondary objectives are to determine the impact of olfactory dysfunction on quality of life, depression, social isolation, and nutrition using validated patient-reported outcome measures, and to identify baseline factors that predict longitudinal changes in olfactory function.

Participants will be followed annually with repeat olfactory testing and outcome assessments to evaluate changes over time and identify predictors of olfactory decline. This study aims to improve understanding of olfactory dysfunction in aging and provide a foundation for future diagnostic and therapeutic strategies.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 50 years or older
  • Ability to follow instructions and understand consent process in English
  • Adequate visual, auditory, or motor functioning to complete items in the test battery or availability of assistance or assist devices to complete tasks

排除标准

  • - Vulnerable populations including prisoners or institutionalized individuals

研究组 & 干预措施

Older Adults With and Without Olfactory Dysfunction

Adults aged 50 years and older enrolled in a prospective cohort study assessing olfactory function, cognition, biomarkers, and quality of life, with annual follow-up. Participants will be classified post hoc into olfactory phenotypes based on testing results.

干预措施: Clinical and Biomarker Assessments (Other)

结局指标

主要结局

Olfactory Function

时间窗: Baseline

Olfactory Threshold, Discrimination, and Identification (TDI scores) using Sniffin' Sticks.

次要结局

  • Change in Olfactory Function Over Time(Year 1 and year 2)
  • Patient-Reported Outcomes(Baseline, Year 1 and year 2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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