Effect of Apollo Wearable on Long COVID-19 Symptoms.

Last updated: October 25, 2023
Sponsor: The Board of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Covid-19

Treatment

N/A

Clinical Study ID

NCT06097442
BOM0001
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • New purchasers of Apollo who haven't started using their Apollo device or previoususers 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 symptomsPsychiatric-related symptoms Sleep-related symptoms Change in quality of life/functionalstatus

Exclusion

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

Study Design

Total Participants: 200
Study Start date:
October 23, 2023
Estimated Completion Date:
March 31, 2025

Study 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.

Connect with a study center

  • The Board of Medicine

    Pittsburgh, Pennsylvania 15219
    United States

    Active - Recruiting

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