Effect of Apollo Wearable on Long COVID-19 Symptoms.

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

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

Study Overview

• Status: Recruiting
• Conditions: Post-acute Sequelae of SARS-COV-2 Infection

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Belinda Tan, MD, PhD; Phone Number: 4129450345; Email: belinda@theboardofmedicine.org
• Study Contact Backup: Name: Ema Perez, BS; Phone Number: 18559220057; Email: clinical_coordinator@apolloneuro.com

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Recruiting
      • The Board of Medicine
      • Contact: Ema Perez, BS; Phone Number: 855-922-0057; Email: clinical_coordinator@apolloneuro.com
      • Principal Investigator: Belinda Tan, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Existing or new customers of Apollo Neuro wellness device

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants with Long-COVID Using Apollo; 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?

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

Collaborators and Investigators

• Sponsor: The Board of Medicine
• Collaborators: Apollo Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: October 20, 2023
• First Submitted That Met QC Criteria: October 20, 2023
• First Posted (Actual): October 24, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 25, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: long-COVID; Apollo
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Chronic Disease; Post-Infectious Disorders; COVID-19; Infections; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: BOM0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No