Cognitive and Immunologic Profiles of Patients With Olfactory Dysfunction After Smell Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
研究概览
简要总结
A research study to assess the baseline olfactory function, mental health status, clinical severity, and immunological profile in patients with smell loss. The impact of a 3-month olfactory training program on smell function, immunological changes, and mental health in patients with smell loss will be evaluated.
The primary purpose of this study is to investigate tissue and blood samples to identify molecules that may be related to smell loss, ultimately aiming to develop future treatments for this condition and correlate with cognition.
详细描述
Adult patients with chronic rhinosinusitis (CRS) with nasal polyps and those experiencing loss of smell will be recruited for the study, along with healthy control participants. We will exclude individuals with unilateral nasal polyps, autoimmune diseases, ciliary disorders, cystic fibrosis, or smell loss due to tumors or trauma.
Assessments will be conducted at baseline and again three months after smell training to evaluate changes in olfactory function. Control patients will only undergo baseline testing with no follow-up assessments needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •Age less than 18 years-old
- •Present to rhinology clinic with CRS with nasal polyps
- •Sense of smell loss for any reason (other than trauma or tumor)
排除标准
- •Patients < 18 years of age
- •Individuals with unilateral nasal polyps
- •Autoimmune diseases
- •Ciliary disorders
- •Cystic fibrosis
- •Smell loss due to tumors or trauma
结局指标
主要结局
Primary Outcome Measure 1: Baseline olfactory function measured by UPSIT score
时间窗: Baseline
At baseline, participants will complete the University of Pennsylvania Smell Identification Test (UPSIT), a standardized 40-item scratch-and-sniff odor identification test. Scores range from 0 to 40, with higher scores indicating better olfactory function. Unit of Measure: Score on a scale from 0 to 40.
Primary Outcome Measure 2: Baseline quality-of-life impact of olfactory dysfunction measured by QOD-NS score
时间窗: Baseline
At baseline, participants will complete the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS), which measures the negative psychosocial impact of olfactory dysfunction. Scores range from 0 to 48, with higher scores indicating greater negative impact of smell loss on quality of life. Unit of Measure: Score on a scale from 0 to 48.
Primary Outcome Measure 3: Baseline cognitive function measured by MMSE score
时间窗: Baseline
At baseline, participants will complete the Mini-Mental State Examination (MMSE), an 11-question cognitive screening tool. Scores range from 0 to 30, with higher scores indicating better cognitive function. Unit of Measure: Score on a scale from 0 to 30.
Primary Outcome Measure 4: Baseline nasal cytokine concentration
时间窗: Baseline
At baseline, nasal secretions will be collected from the middle meatus using a polyvinyl alcohol (PVA) sponge and analyzed for cytokine concentrations by multiplex immunoassay. Each cytokine concentration will be reported separately and will not be combined with questionnaire or cognitive assessment scores. Unit of Measure: pg/mL for each cytokine concentration reported separately.
次要结局
- Secondary Outcome Measure 1: Change from baseline to Month 3 in olfactory function measured by UPSIT score(Baseline to Month 3)
- Secondary Outcome Measure 2: Change from baseline to Month 3 in quality-of-life impact of olfactory dysfunction measured by QOD-NS score(Baseline to Month 3)
- Secondary Outcome Measure 3: Change from baseline to Month 3 in cognitive function measured by MMSE score(Baseline to Month 3)
- Secondary Outcome Measure 4: Change from baseline to Month 3 in nasal cytokine concentration(Baseline to Month 3)