Recruiting

Long COVID-19

Sponsor:

Scripps Translational Science Institute

Code:

NCT05741112

Conditions

Long COVID

Postural Orthostatic Tachycardia Syndrome

Dysautonomia

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Wearable device

Study Details

Brief 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.

Conditions

Long COVID

Postural Orthostatic Tachycardia Syndrome

Dysautonomia

Myalgic Encephalomyelitis

Chronic Fatigue Syndrome

Study ID

NCT05741112

Start date

Nov 16, 2023

Status verified date

May, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100500 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Control: study provided wearables

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.

other: Treatment: study provided wearables

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.

other: Control: self provided wearables

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.

other: Treatment: self provided wearables

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.

Interventions

Wearable 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.

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Andrea Goosen

0000000000agoosen@scripps.edu

Romina Foster-Bonds

rfoster@scripps.edu

Locations

Scripps Research

Recruiting

La Jolla, California, United States, 92037

More Information

Sponsor

Scripps Translational Science Institute

Last update posted

May 11, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Scripps Translational Science Institute on 2025-05-11.