Acupuncture Therapy for COVID-Related Olfactory Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores
研究概览
简要总结
This study is looking at the role of acupuncture as a treatment for olfactory dysfunction in patients who tested positive for COVID-19.
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
- •18 years or older.
- •Patients with post-viral olfactory dysfunction > 4 weeks.
- •History of positive COVID-19 PCR.
排除标准
- •Less than 18 years of age.
- •Active sinus infection.
- •New diagnosis of untreated CRS.
- •Prior diagnosis of dementia or Parkinson's disease.
- •Prior head trauma or neurosurgical procedure resulting in olfactory loss.
- •Patients who do not speak or read English.
- •Patients unable to understand and sign the study consent.
研究组 & 干预措施
Acupuncture Therapy Group
Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
干预措施: Acupuncture Therapy (Device)
Acupuncture Therapy Group
Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
干预措施: Budesonide (Drug)
Acupuncture Therapy Group
Subjects will undergo ten sessions of acupuncture therapy with a licensed acupuncturist in addition to the standard of care.
干预措施: Olfactory Training (Other)
Standard of Care
Subjects will be treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
干预措施: Budesonide (Drug)
Standard of Care
Subjects will be treated with two times daily budesonide rinses and olfactory (sense of smell) training. This is considered the current standard of care in the treatment of olfactory dysfunction.
干预措施: Olfactory Training (Other)
结局指标
主要结局
Change in University of Pennsylvania Smell Identification Test (UPSIT) Scores
时间窗: Baseline, post-treatment approximately 12 weeks
The 40-item UPSIT is a measurement of the ability to detect odors where microencapsulated odorants on a strip are released by scratching. Each item is scored from 0 (did not correctly detect the odor) to 1 (correctly detected the odor). Total scores range from 0-40 with higher scores indicating better smell and lower scores indicating worse smell.
次要结局
- Change in Patient-reported Subjective Olfactory Loss(Baseline, post-treatment approximately 12 weeks)
- Change in Sino-Nasal Outcome Test (SNOT-22)(Baseline, post-treatment approximately 12 weeks)
研究者
Janalee K. Stokken
Principal Investigator
Mayo Clinic