Status:
COMPLETED
Vagal Approaches on Long COVID-19
Lead Sponsor:
Leidos Life Sciences
Conditions:
Long COVID Symptoms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 n...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Tested positive by any test for acute COVID-19 and/or have ICD-10 code for COVID-19 in their electronic health records (EHR)
- 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
- Have persistent COVID-19 symptoms 3 months following resolution of acute COVID-19 infection as indicated by a negative COVID-19 test
- 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)
- Participants must have auditory headphones; over the ear headphones or earbuds
- Participants must be at least 18 years of age, inclusive, at the time of signing the informed consent
- Capable of understanding and providing signed informed consent
- Participants must have a smart phone
- Reliable access to internet via browser installed on a smartphone
Exclusion
Key Trial Info
Start Date :
October 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2025
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT07190105
Start Date
October 27 2025
End Date
December 11 2025
Last Update
January 7 2026
Active Locations (1)
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1
Virtual
Frederick, Maryland, United States, 21703