Vagal Nerve Stimulation for Long COVID Symptom Relief
Sonocea Sonic Augmentation Technology (SAT)
+ Truvaga Electrical Vagus Nerve Stimulator
COVID-19+15
+ Post-Acute COVID-19 Syndrome
+ Post-Infectious Disorders
Other Study
Summary
Study start date: October 27, 2025
Actual date on which the first participant was enrolled.This study aims to see if two general wellness products can help people who have lingering symptoms after having COVID-19, often referred to as Long COVID. These products are designed to stimulate the vagus nerve, which plays a role in managing stress, mood, breathing, heart rate, inflammation, and digestion. The study is important because it seeks to find new ways to support those experiencing ongoing symptoms after COVID-19, which can be disruptive to daily life and challenging to manage. Participants in the study will use a Fitbit device to monitor their health, tracking data like physical activity levels and heart rate patterns. They will also fill out surveys to detail their symptoms and experiences throughout the study. All of this information will be collected to create a repository, allowing for a shared understanding of how Long COVID affects individuals and whether the wellness products have a positive impact on their symptoms.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.546 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Tested positive by any test for acute COVID-19 and/or have ICD-10 code for COVID-19 in their electronic health records (EHR) 2. Any patient having the ICD-10 code for post-acute sequelae of COVID-19 (PASC) within their EHR, or any patient who has evidence of a Long COVID clinic visit within their EHR 3. Have persistent COVID-19 symptoms 3 months following resolution of acute COVID-19 infection as indicated by a negative COVID-19 test 4. Self-identified as having Long COVID based on symptomology: a. Symptoms must include any combination of the following: (ICD-10 codes shown): * Shortness of breath (R06.02, R06.00, or R06.09) * Fatigue (R53.83, or R53.82) * Cognitive impairment (G31.84 or R41.9) * Mental, Behavioral, and Neurodevelopmental disorders (F01-F99) * Postural orthostatic tachycardia syndrome (POTS) (I49.8) 5. Participants must have auditory headphones; over the ear headphones or earbuds 6. Participants must be at least 18 years of age, inclusive, at the time of signing the informed consent 7. Capable of understanding and providing signed informed consent 8. Participants must have a smart phone 9. Reliable access to internet via browser installed on a smartphone
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location