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NCT Number: NCT05741112

The Long COVID-19 Wearable Device Study

To further characterize Long COVID-19 by collecting data from individuals who already own wearable devices or are provided with a wearable device along with basic and enhanced educational materials to determine if both can improve Long COVID-19 symptom management and post-exertional malaise.

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Key information

Conditions

Long COVID Autonomic Nervous System Diseases COVID-19 Chronic Disease Chronic Fatigue Syndrome Coronaviridae Infections Coronavirus Infections Disease Attributes Dysautonomia Encephalomyelitis Fatigue Syndrome, Chronic Infections Long Covid19 Lung Diseases Muscular Diseases Musculoskeletal Diseases Myalgic Encephalomyelitis Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nidovirales Infections Orthostatic Intolerance Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders Postural Orthostatic Tachycardia Syndrome Primary Dysautonomias RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scripps Research

La Jolla, California, 92037, United States

Location status: Recruiting

Location contact

Andrea Goosen

CONTACT

About this study

This study will have two components:

One study group will consist of up to 100,000 individuals who own wearable devices and are willing to share their data. These participants will be randomized and will receive educational materials. The investigators will study these dynamic wearable data along with participant survey responses that focus on diagnoses, symptoms, and quality of life to improve disease characterization and understanding of differences within and between individuals.

The other group in the randomized trial will participants who do not already own a wearable device. The study will distribute wearable devices and pacing educational materials to 500 individuals who do not already own them and experience post-exertional malaise, or the worsening of symptoms following exertion.

The investigators hypothesize that access to personalized information from a wearable device will enable participants to reduce post-exertional malaise. The investigators will include up to 25% individuals whose post-exertional malaise is caused by a condition other than Long COVID-19.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is at least 18 years old.
  • Has a self/and or physician diagnosis of:
  • Long COVID (based on the WHO working definition),
  • ME/CFS (myalgic encephalomyelitis / chronic fatigue syndrome, self-diagnosis based on IOM criteria), and/or
  • POTS (Postural Orthostatic Tachycardia Syndrome).
  • Is interested in tools to manage ME/CFS, POTS, and/or Long COVID symptoms.
  • Owns a wearable device they are willing to use for this study or does not own a device and agrees to utilize a study-provided one.
  • Agrees to wear the device throughout the study period, share the data with the study, and sync data at least weekly.
  • Has access to a smartphone or tablet to enable syncing wearable data and viewing device feedback.
  • Agrees to disclose involvement in other ME/CFS, POTS, and/or Long COVID interventions such as medical treatment, self-management, and other interventional studies.
  • Agrees to complete at least 75% of the study surveys.

Exclusion criteria

  • As long as they meet inclusion there is no exclusion

Treatment and study plan

wearable device

Device

The treatment group will receive their wearable device and the enhanced education at the start of the study. Their outcomes will be compared with the control group who will receive at 3 months.

Other names: Educational materials

Primary outcomes

  1. Primary Objective 1:Assess the effect of study-provided devices and enhanced educational materials to manage Long COVID-19 symptom severity, compared to general educational materials alone using data from participants survey responses.

    Time frame: 3 months

    Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change in the weekly survey responses.

  2. Primary Objective 2: Collate a unique longitudinal dataset combining patients' demographics, symptoms, symptom severity, quality of life, and sensor data including sleep, activity, heart rate, heart rate variability, and Body Battery.

    Time frame: 12 months

    Will measure relapse symptom frequency, symptom severity, pain, quality of life and overall health through the analysis and measurement of change from the baseline survey to the quarterly survey.

Secondary outcomes

  1. Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.

    Time frame: 12 months

    Conduct within-subject comparisons on the primary and secondary endpoints listed above but such that the investigators are assessing the change between the baseline measurement at month zero and that of the quarterly survey nine months after the distribution of the device and/or enhanced education materials.

Other outcomes

  1. Exploratory Objective: Assess whether individuals who enroll in the study with their own wrist-worn wearable device and receive educational materials see a decrease in symptom severity and whether this differs by device brand and/or feature.

    Time frame: 12 months

    Cross-referencing heart rate patterns with participant-provided symptoms and diagnoses to identify correlations; identify underlying signals in surveys and/or wearable data that may help differentiate those who will recover within six months from those who will not recover for years; identify correlates with which individuals experience worsening symptoms over time, such as whether consistent reduced heart rate variability affects long-term symptoms as it does short-term symptoms. The self-provided wearable cohort can share data from the complete history of their wearable device (and in some cases the history from their ownership of a device of the same brand), therefore the investigators can also conduct within-subject analysis for those that were using a wearable device prior to their COVID-19 infection.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Goosen

CONTACT

[email protected]

0000000000

Romina Foster-Bonds

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Scripps Translational Science Institute

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 23, 2023
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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