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临床试验/NCT06097442
NCT06097442招募中不适用

Effect of Apollo Wearable on Symptoms Related to Post-acute Sequelae SARS-CoV-2 Infection (PASC).

The Board of Medicine1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年10月23日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Post-Covid-19 Functional Status Scale (PCFS)

研究概览

简要总结

The purpose of this study is to examine how Apollo wearable use impacts symptoms and quality of life following long COVID.

详细描述

Post-Acute Sequelae of SARS-CoV-2 infection (PASC), also known as long-COVID, is a syndrome that describes the persistence of symptoms or other sequelae weeks or months after initial SARS-CoV-2 infection. Limited evidence exists for effective treatments for this syndrome.

In this observational study, the investigators will examine the effects of Apollo wearable use on symptoms and quality of life related to long-COVID. The Apollo Neuroscience System (combined wearable and mobile application) offers a convenient, non-invasive, non-habit-forming wearable solution to improve performance and recovery under stress in children and adults. Our sample will be composed of new purchasers of Apollo or previous users of Apollo who haven't used Apollo in the preceding 14 days who are currently experiencing symptoms related to long-COVID according to PASC (self report).

Clinically validated survey tools will be administered upon enrollment in the study to assess baseline symptoms and quality of life. Once consented and enrolled in the study, participants will complete 7 monthly surveys for 6 months. Usage data from subjects' use of the wearable is also saved on the wearable directly and periodically uploaded to Apollo Neuroscience's secure and confidential database to be stored for analysis. Participants will first complete a screener survey to assess eligibility to participate. Demographic information and medication, substance, and treatment usage will also be collected.

Participants may choose to provide biometric data at their discretion for purposes of comparison at least 8 weeks before the study period, during the study period for 6 months, and at most 8 weeks after the study period. With regular Apollo use, the investigators expect to see an improvement in the physical, cognitive, and psychological symptoms associated with PASC. Initial analysis will compare subjects' baseline scores before Apollo use to scores during/after Apollo and the scores of subjects who used Apollo according to the study protocol and the scores of those who did not. Information gained from this study will help evaluate the use of Apollo as a potential non-invasive and accessible solution to aid in reducing long-COVID symptoms.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • New purchasers of Apollo who haven't started using their Apollo device or previous users of Apollo who haven't used Apollo in the preceding 14 days.
  • Age 18 years or over
  • Currently experiencing symptoms related to long-COVID according to PASC (self report).
  • Must be experiencing PASC symptoms in at least one of the following domains:
  • Respiratory-related symptoms Fatigue-related symptoms Neurologic-related symptoms Psychiatric-related symptoms Sleep-related symptoms Change in quality of life/functional status

排除标准

  • Inability to use or access a compatible Android or iOS smartphone
  • Are unable to complete consent and questionnaires written in English
  • Current resident of a European Union (EU) country

结局指标

主要结局

Post-Covid-19 Functional Status Scale (PCFS)

时间窗: Monthly for 6 months

Post-Covid-19 Functional Status Scale (PCFS) will be used to assess participants' functional recovery following a COVID-19 diagnosis.

次要结局

  • Modified Medical Research Council (mMRC) Dyspnea Scale(Monthly for 6 months)
  • Fatigue Severity Scale (FSS)(Monthly for 6 months)
  • EuroQol-5D-5L (EQ-5D)(Monthly for 6 months)
  • Pittsburgh Sleep Quality Index (PSQI)(Monthly for 6 months)
  • Neurobehavioral Symptom Inventory (NSI)(Monthly for 6 months)

研究者

发起方
The Board of Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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