Effect of Apollo Wearable on Long COVID-19 Symptoms.

NCT06097442 | Unknown

• 1 other identifier: BOM0001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-acute Sequelae of SARS-COV-2 Infection

Keywords

long-COVID; Apollo

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Modified Medical Research Council (mMRC) Dyspnea Scale

  Monthly for 6 months

• EuroQol-5D-5L (EQ-5D)

  Monthly for 6 months

• Neurobehavioral Symptom Inventory (NSI)

  Monthly for 6 months

• Fatigue Severity Scale (FSS)

  Monthly for 6 months

• Pittsburgh Sleep Quality Index (PSQI)

  Monthly for 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Existing or new customers of Apollo Neuro wellness device

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Board of Medicine: lead
• Apollo Neuroscience, Inc.: collaborator

Study Sites (1)

The Board of Medicine

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Belinda Tan, MD, PhD

CONTACT

4129450345; belinda@theboardofmedicine.org

Ema Perez, BS

CONTACT

18559220057; clinical_coordinator@apolloneuro.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 24, 2023
• Study Start: October 23, 2023
• Primary Completion: December 1, 2024
• Study Completion: March 1, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)