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Clinical Trials/NCT06097442
NCT06097442RecruitingNot Applicable

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

The Board of Medicine1 site in 1 country200 target enrollmentStarted: October 23, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
Post-Covid-19 Functional Status Scale (PCFS)

Study Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Post-Covid-19 Functional Status Scale (PCFS)

Time Frame: Monthly for 6 months

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

Secondary Outcomes

  • 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)

Investigators

Sponsor
The Board of Medicine
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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