Long COVIDNCT05741112
The Long COVID-19 Wearable Device Study
A study testing Wearable device in people with Long COVID and Postural Orthostatic Tachycardia Syndrome, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia
- What is being tested?
- Wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100,500 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- As long as they meet inclusion there is no exclusion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romina Foster-Bonds contact
United States1 site, 1 recruiting
- Recruiting
Scripps Research
La Jolla, California, 92037
Andrea Goosen
About this 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.
Read the detailed description
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.
- Conditions
- Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Long Covid19
- Being tested
- Wearable device
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Postural Orthostatic Tachycardia Syndrome, Autonomic Nervous System Diseases, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable deviceDevice
Also called Educational materials
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.
| Study group | Role | What they receive |
|---|---|---|
| Control: study provided wearables | Other | Following consent and the completion of the baseline assessments the control group will receive basic education on symptom management. At the 3 month timepoint they will be prompted to order their device and receive enhanced education that will provide information on how wearable devices can be used to monitor and manage symptoms. Receives: Device: Wearable device |
| Treatment: study provided wearables | Other | Following consent and the completion of the baseline assessments the treatment group will be prompted to order their device and receive basic education on symptom management along with the enhanced education on wearable devices. Receives: Device: Wearable device |
| Control: self provided wearables | Other | Following consent and the completion of the baseline assessments the control group will receive basic education on symptom management. At the 3 month timepoint they will be receive enhanced education that will provide information on how wearable devices can be used to monitor and manage symptoms. Receives: Device: Wearable device |
| Treatment: self provided wearables | Other | Following consent and the completion of the baseline assessments the treatment group will receive basic education on symptom management along with the enhanced education on wearable devices. Receives: Device: Wearable device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 3 months
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.
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.
Measured: 12 months
Secondary outcomes (1)
Secondary Objective: Assess the longitudinal impact of sustained use of the study-provided devices and enhanced educational materials on symptom severity.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start16 Nov 2023
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.
- Masking
- None (open label)
- Enrolment
- 100,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julia Moore Vogel, Scripps Translational Science Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741112
- Sponsor's protocol ID
- LCWS 001
- Status last verified
- May 2025
- First submitted
- 17 Feb 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Long COVID-19 Wearable Device Study
- ClinicalTrials.gov ID
- NCT05741112
- Acronym / sponsor ID
- LCWS 001
- Conditions
- Long COVID, Postural Orthostatic Tachycardia Syndrome, Dysautonomia, Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Long Covid19
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100,500 participants (estimated)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- All participants will have a diagnosis of Long COVID-19, Chronic Fatigue Syndrome or Postural Orthostatic Tachycardia Syndrome.
| Arm | Type | Receives |
|---|---|---|
| Control: study provided wearables | Other | Device: Wearable deviceFollowing consent and the completion of the baseline assessments the control group will receive basic education on symptom management. At the 3 month timepoint they will be prompted to order their device and receive enhanced education that will provide information on how wearable devices can be used to monitor and manage symptoms. |
| Treatment: study provided wearables | Other | Device: Wearable deviceFollowing consent and the completion of the baseline assessments the treatment group will be prompted to order their device and receive basic education on symptom management along with the enhanced education on wearable devices. |
| Control: self provided wearables | Other | Device: Wearable deviceFollowing consent and the completion of the baseline assessments the control group will receive basic education on symptom management. At the 3 month timepoint they will be receive enhanced education that will provide information on how wearable devices can be used to monitor and manage symptoms. |
| Treatment: self provided wearables | Other | Device: Wearable deviceFollowing consent and the completion of the baseline assessments the treatment group will receive basic education on symptom management along with the enhanced education on wearable devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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).
Key exclusion criteria (1 listed)
- As long as they meet inclusion there is no exclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable deviceAlso: Educational materialsThe 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. | Device | Control: self provided wearables, Control: study provided wearables, Treatment: self provided wearables, Treatment: study provided wearables |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Undecided. The investigators may share the coded study data with researchers outside of Scripps Research. Before doing so, they will ensure that nothing in the data can identify the participant directly.
Related trials for Long COVID
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Romina Foster-Bonds contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable device in people with Long COVID and Postural Orthostatic Tachycardia Syndrome, run by Scripps Translational Science Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Goosen (0000000000, agoosen@scripps.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.