Official Title
Impact of Vagal Approaches on Symptomatology in Long COVID Participants
Brief Summary

The purpose of this study is to explore whether two general wellness products, alone orcombined, can support individuals experiencing Long COVID symptoms. Both wellnessproducts stimulate the vagus nerve - a nerve that helps regulate stress, relaxation,mood, breathing, heart rate, inflammation, and digestion.The investigators will use a Fitbit to track participants' health measurements including,but not limited to, activity, heart rate, and heart rate variability, and participantswill be asked to complete surveys about their experience. This information will becollected into a repository where participants can share their experiences with LongCOVID symptoms.

Detailed Description

Not Provided

Not yet recruiting
Long COVID Symptoms

Other: Sonocea Sonic Augmentation Technology (SAT)

The Sonocea Sonic Augmentation Technology (SAT) is a sound-based approach delivered via
headphones through a smartphone application. The approach uses music soundscapes that
have been standardized in format, intensity and duration.

Other: Truvaga Electrical Vagus Nerve Stimulator

The Truvaga Electrical Vagus Nerve Stimulator is a general wellness product that sends
gentle electrical signals through the skin to stimulate the vagus nerve on the neck.

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Locations

Not Provided

Not Provided

Leidos Life Sciences
NCT Number
Keywords
Covid
long COVID
Covid-19
Fitbit
Sonic Augmentation Technology (SAT)
Electrical Vagus Nerve Stimulator
General Wellness Product
Autonomic Nervous System
Vagus Nerve
Sonocea
Truvaga
MeSH Terms
Post-Acute COVID-19 Syndrome
COVID-19