Olfactory Retraining Therapy and Budesonide Nasal Rinse for Anosmia Treatment in Patients Post-CoVID 19. A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from Baseline Snap and Sniff Threshold Test at 3 months
研究概览
简要总结
The study will be a randomized controlled trial, involving patients with hyposmia/anosmia of onset immediately after an upper respiratory viral illness, assigned to three distinct study arms. Nasal irrigations will be prescribed to all three groups (BID). In addition, one arm will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care) and act as a control group. The second group will receive an essential oil retraining kit, whereas the third group will receive the same olfactory training kit and a prescription to use budesonide with the nasal irrigations. Olfactory scores will be tested at the enrollment, 3 months and at 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 years of age or older
- •Hyposmia/anosmia of onset immediately after an upper respiratory viral illness confirmed on Snap n' Sniff threshold testing,
- •Capable, in the opinion of the primary investigator, of providing informed consent to participate in the study. Participants are required to sign an informed consent form indicating they understand the purpose and nature of the study, and that they are willing to participate.
排除标准
- •active cigarette smoker
- •chronic rhinosinusitis
- •head trauma with loss of consciousness
- •inability to read/understand English
- •previous hyposmia/anosmia complaint
- •pregnancy
- •previous sinus
- •skull base or brain surgery
- •current participation in another clinical trial at the time of initial visit
研究组 & 干预措施
Control Group
The participants, randomly assigned to this arm, will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care). Besides, it will be prescribed nasal irrigation twice a day.
干预措施: smell household Items (Other)
Control Group
The participants, randomly assigned to this arm, will receive a paper hand-out about post-viral anosmia with instructions to smell common household items (current care). Besides, it will be prescribed nasal irrigation twice a day.
干预措施: Nasal Irrigation (Other)
Olfactory Retraining Group
The participants, randomly assigned to this arm, will receive instructions on olfactory retraining and will also be given an essential oil retraining kit, which they will use twice a day. Besides, it will be prescribed nasal irrigation twice a day.
干预措施: Olfactory retraining (Other)
Olfactory Retraining Group
The participants, randomly assigned to this arm, will receive instructions on olfactory retraining and will also be given an essential oil retraining kit, which they will use twice a day. Besides, it will be prescribed nasal irrigation twice a day.
干预措施: Nasal Irrigation (Other)
Olfactory Retraining_Budesonide Group
The participants, randomly assigned to this arm, will receive instructions on olfactory retraining, the olfactory training kit and it will be prescribed nasal irrigation with Budesonise, twice a day.
干预措施: Olfactory retraining (Other)
Olfactory Retraining_Budesonide Group
The participants, randomly assigned to this arm, will receive instructions on olfactory retraining, the olfactory training kit and it will be prescribed nasal irrigation with Budesonise, twice a day.
干预措施: corticosteroid nasal irrigation (Drug)
结局指标
主要结局
Change from Baseline Snap and Sniff Threshold Test at 3 months
时间窗: 3 months
Score from the Snap and Sniff Olfactory Test results
Change from baseline Smell Identification Test (SIT) at 3 months
时间窗: 3 months
Score from the Smell Identification test results.
Change from baseline Smell Identification Test (SIT) at 6 months
时间窗: 6 months
Score from the Smell Identification test results.
Change from Baseline Snap and Sniff Threshold Test at 6 months
时间窗: 6 months
Score from the Snap and Sniff Olfactory Test results
次要结局
- Change from baseline SF-36 health survey at 6 months(6 months)
- Change from baseline QOD-NS at 3 months(3 months)
- Adherence to the Study Protocol(6 months)
- Recovery(6 months)
- Change from baseline SF-36 health survey at 3 months(3 months)
- Change from baseline QOD-NS at 6 months(6 months)