Steroid Nasal Irrigation for Flavor Evaluation and Detection (SNIFFED) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Pre- and Post-intervention Difference in Functional Connectivity Before and After Smell Training.
研究概览
简要总结
The purpose of this research study is to examine the efficacy of a 12-week smell training intervention for participants with olfactory dysfunction following an infection of the upper respiratory tract.
详细描述
Olfactory dysfunction affects up to fifteen percent of the general population and can cause significant psychosocial distress including decreased appetite, reduced self-hygiene, and mood disturbances.
This study aims to study the efficacy of smell training for patients with olfactory dysfunction following a viral upper respiratory tract infection. Eligible participants will complete a 30-day course of budesonide nasal saline irrigation. Participants who do not show improvement in their olfaction based on composite smell and taste tests will be eligible to receive a baseline resting-state fMRI (rs-fMRI) and complete a 12-week smell training intervention program. Smell training involves participants smelling 4 odors (phenyl ethyl alcohol, eucalyptus, lemon, and eugenol) twice a day for 12 weeks. Following completion of smell training, participants will undergo repeat smell and taste tests as well as rs-fMRI to ascertain the efficacy of smell training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70
- •Anosmia or hyposmia (UPSIT <34 (male), UPSIT <34 (female); Sniffin' Sticks threshold below 5.5)
排除标准
- •Inability to understand English
- •Current smoker or history of smoking within the past 6 months
- •Current nasal polyps
- •Exposure to head and or/neck radiation
- •Exposure to chemotherapy
结局指标
主要结局
Pre- and Post-intervention Difference in Functional Connectivity Before and After Smell Training.
时间窗: 12 weeks
Baseline and post-intervention connectivity within and between regions of interest in the olfactory and olfactory related networks using resting state fMRI will be obtained. Resting-state connectivity was analyzed using the CONN toolbox version 18b (https://web.conn-toolbox.org/) and SPM12, version 7487 (Wellcome Trust Centre for Neuroimaging). Functional connectivity values (Fisher z-transformed Pearson correlation coefficients) were compared using a paired, 2-tailed t test and corrected for multiple comparisons. p\<0.05 was considered to be significant.
次要结局
- Pre- and Post-intervention Difference in Smell Testing Before and After Smell Training(12 weeks)
- Pre and Post Difference in QOD-NS After Smell Training(12 weeks)
- Subjective Response to Smell Training Intervention(12 weeks)
- Comparison of Olfactory Network in Healthy Controls to Study Participants(1 week)
- Pre- and Post-intervention Difference in Smell Testing Before and After Budesonide Treatment(30 days)