Vagal Approaches on Long COVID-19

Leidos

Status: Completed

Conditions: Long COVID Symptoms

Treatments: Other: Sonocea Sonic Augmentation Technology (SAT); Other: Truvaga Electrical Vagus Nerve Stimulator

Study type: Interventional

Funder types: Industry

Identifiers

NCT07190105

MCDC2015-003 (Other Grant/Funding Number)

LDOS-25-001

Details and patient eligibility

About

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.

Enrollment: 546 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

546 participants in 4 patient groups

Sonocea Sonic Augmentation Technology (SAT) General Wellness Product

Experimental group

Description:

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.

Treatment:

Other: Sonocea Sonic Augmentation Technology (SAT)

Truvaga Electrical Vagus Nerve Stimulator General Wellness Product

Experimental group

Description:

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.

Treatment:

Other: Truvaga Electrical Vagus Nerve Stimulator

Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products

Experimental group

Description:

Participants enrolled in this arm will use both the Sonocea SAT and Truvaga Electrical Vagus Nerve Stimulator general wellness products.

Treatment:

Other: Truvaga Electrical Vagus Nerve Stimulator

Other: Sonocea Sonic Augmentation Technology (SAT)

Control (No Intervention)

No Intervention group

Description:

Participants enrolled in this arm will not use either wellness product.