Effect of Apollo Wearable on Long COVID-19 Symptoms.

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

Detailed Description
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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.

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

Conditions
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Post-acute Sequelae of SARS-COV-2 Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with Long-COVID Using Apollo<br>Participants with long-COVID symptoms who have consented to be part of this study will use an Apollo device according to a suggested schedule pre-set within their Apollo app, which participants can alter as they see fit. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Covid-19 Functional Status Scale (PCFS) | Post-Covid-19 Functional Status Scale (PCFS) will be used to assess participants' functional recovery following a COVID-19 diagnosis. | Monthly for 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medical Research Council (mMRC) Dyspnea Scale | The Modified Medical Research Council (mMRC) Dyspnea Scale will be used to assess dyspnea (labored breathing). | Monthly for 6 months | 
| EuroQol-5D-5L (EQ-5D) | The EuroQol-5D-5L (EQ-5D) will measure health in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Monthly for 6 months | 
| Neurobehavioral Symptom Inventory (NSI) | The Neurobehavioral Symptom Inventory (NSI) will be used to assess neurobehavioral symptoms. | Monthly for 6 months | 
| Fatigue Severity Scale (FSS) | The Fatigue Severity Scale (FSS) will be used to measure the severity of fatigue symptoms. | Monthly for 6 months | 
| Pittsburgh Sleep Quality Index (PSQI) | The Pittsburgh Sleep Quality Index (PSQI) will be used to quantify sleep quality and disturbances over a month interval at a time. | Monthly for 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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long-COVID, Apollo