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Purpose

The purpose of this study is to explore whether two general wellness products, alone or combined, can support individuals experiencing Long COVID symptoms. Both wellness products 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 participants will be asked to complete surveys about their experience. This information will be collected into a repository where participants can share their experiences with Long COVID symptoms.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Sonocea Sonic Augmentation Technology (SAT) General Wellness Product 		Participants enrolled in this arm will listen to a sound-based approach, delivered via headphones through a smartphone application. The session participants will listen to consists of structured music soundscapes that have been standardized in format, intensity, and duration for research purposes.
  • 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.
Experimental
Truvaga Electrical Vagus Nerve Stimulator General Wellness Product 		Participants enrolled in this arm will use the Truvaga Electrical Vagus Nerve Stimulator general wellness product, which sends gentle electrical signals through the skin to stimulate the vagus nerve on the neck.
  • 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.
Experimental
Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products 		Participants enrolled in this arm will use both the Sonocea SAT and Truvaga Electrical Vagus Nerve Stimulator general wellness products.
  • 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.
No Intervention
Control (No Intervention) 		Participants enrolled in this arm will not use either wellness product.

Recruiting Locations

More Details

NCT ID
NCT07190105
Status
Completed
Sponsor
Leidos Life Sciences

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.