Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Aromha Longitudinal Smell Test
研究概览
简要总结
The purpose of this study is to learn more about how to better track smell recovery in people who have been infected with the SARS-CoV-2 virus (which causes COVID-19). Many people who have been infected by this virus develop changes in their sense of smell (olfaction). We are interested in measuring smell function objectively via smell cards that test odor intensity, identification, and discrimination. Objective and precise olfactory testing that can be performed in the convenience of one's home will help identify people with smell loss after infection by SARS-CoV-2. We will use results from this test to better understand the relationship between SARS-CoV-2 infection and recovery of olfactory function and to learn whether the AROMHA longitudinal smell test is a reliable olfactory function tracking tool to quantify smell loss in the context of COVID infection. These results may inform the design of therapeutic clinical trials to accelerate the recovery of smell function.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For anosmic patients/healthy controls:
- •Inclusion criteria
- •Known anosmia (for anosmic patients only)
- •Age greater than or equal to 18
- •Access to phone, tablet or computer connected to the internet.
排除标准
- •1. Known odor-evoked adverse effects, e.g. asthma.
- •For asymptomatic participants:
- •Inclusion criteria
- •No symptoms of COVID infection at the time of enrollment.
- •Age greater than or equal to 18
- •Access to phone, tablet or computer connected to the internet.
- •Exclusion criteria
- •1. Known odor-evoked adverse effects, e.g. asthma.
- •For participants with COVID-19-related smell loss:
- •Inclusion criteria
- •Past infection of SARS-CoV-2 virus as validated by a previous PCR or antigen test
- •Age greater than or equal to 18
- •Access to phone, tablet or computer connected to the internet.
- •Exclusion criteria
- •1. Known odor-evoked adverse effects, e.g. asthma.
研究组 & 干预措施
Anosmic patients
Anosmic patients will be recruited from Dr. Albers Smell Clinic at MGH and through past participation in research with known anosmia and permission to recontact. All consent and testing will occur on a phone/tablet app in the participant's home.
干预措施: AROMHA Longitudinal Smell Test (Device)
Asymptomatic participants / Healthy participants
Asymptomatic participants recruited in a hospital setting (eg. healthcare workers and household members of symptomatic patients who are potentially COVID positive). No symptoms of COVID infection at the time of enrollment. Potential or definite exposure to SARS-CoV-2 virus without symptoms of upper respiratory infection (smell loss, taste loss, fever, myalgia, cough, nasal congestion, runny nose, shortness of breath). All consent and testing will occur on a phone/tablet app in the participant's home.
干预措施: AROMHA Longitudinal Smell Test (Device)
Participants with a confirmed COVID-19 infection or related smell loss
Individuals who tested positive for SARS-CoV2 by an objective PCR or antigen test will be recruited to evaluate smell function weekly over 3 months. All consent and testing will occur on a phone/tablet app in the participant's home.
干预措施: AROMHA Longitudinal Smell Test (Device)
PASC
Known history of CSD (chemosensory dysfunction) associated with a COVID-19 infection characterized in Dr.Lora Bankova's clinical study (MGB) .
干预措施: AROMHA Longitudinal Smell Test (Device)
结局指标
主要结局
Aromha Longitudinal Smell Test
时间窗: 12 weeks
The Aromha Smell Test is a battery of 18 odors across 6 smell cards. The subject smells each of the 3 scents per card to determine smell intensity, identification, and discrimination. Increased number of correct responses indicates better sense of smell. We will evaluate previously diagnosed anosmic patients.
次要结局
- Brief Smell Identification Test (BSIT)(12 weeks)
研究者
Mark W Albers
Frank Wilkens and Family Endowed Scholar/ Asst. Prof. Neurology
Massachusetts General Hospital