Vagal Approaches on Long COVID-19

NCT07190105 | Completed

• 2 other identifiers: LDOS-25-001MCDC2015-003
• Study Type: interventional
• Target: 546
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Long COVID Symptoms

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

Outcome Measures

Primary Outcomes (14)

• Patient Health Questionnaire-8 (PHQ-8)

  The PHQ-8 is a gold-standard screening tool for major depressive disorder, endorsed by the CDC and WHO, with strong criterion validity and sensitivity to clinical change.

  Week 0, Week 4 and Week 8

• Generalized Anxiety Disorder-7 (GAD-7)

  The GAD-7 captures both somatic and cognitive components of generalized anxiety. Extensively used in both clinical and epidemiological contexts, the GAD-7 shows excellent internal consistency (α \> 0.90) and convergent validity with clinician-administered diagnostic tools.

  Week 0, Week 4 and Week 8

• PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5)

  The Abbreviated PCL-5 captures re-experiencing, avoidance, hyperarousal, and mood alterations. The Abbreviated PCL-5 is validated across diverse populations and is widely used in both military and civilian trauma research. It is recommended by the National Center for PTSD.

  Week 0, Week 4 and Week 8

• Symptom Burden Questionnaire - Long COVID (SBQ-LC)

  The SBQ-LC measures the intensity and impact of Long COVID symptoms, offering key insight into the ongoing symptom burden experienced. The SBQ-LC demonstrates strong psychometric properties with high internal consistency across subscales and good convergent validity with established measures of symptom severity and functional impairment. It has been validated across diverse Long COVID populations in multiple clinical settings.

  Week 0, Week 4 and Week 8

• Body Perception Questionnaire (BPQ)

  The BPQ assesses self-reported autonomic reactivity and has been used in a range of international neural, behavioral, and clinical studies and translated into several languages. It has been corroborated with sensor-based measures of autonomic function.

  Week 0, Week 4 and Week 8

• Benefits Scale

  The Benefits Scale assesses biobehavioral state, including the ability to quiet thoughts, awareness of bodily rhythms, breathing, muscular relaxation, physical pain levels, and emotional states such as peacefulness, relaxation, anxiety, irritability, feeling overwhelmed, worry about the future, and vulnerability.

  Weekly

• Sleep Metrics

  The investigators will use the sleep categories of accumulated minutes of deep sleep, REM sleep, light sleep, and wakefulness during the night to provide us with sleep architecture.

  Weekly

• Resting Heart Rate

  Monitoring resting heart rate will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are effective in lowering the elevated resting heart rate often observed in Long COVID patients via parasympathetic stimulation.

  Weekly

• Steps

  Monitoring steps will allow us to assess whether SAT and Truvaga Electrical Vagus Nerve Stimulator are associated with an increase in average daily steps, which may indicate enhanced functional capacity or reduced fatigue.

  Weekly

• Breathing Rate

  This measurement captures a user's average breaths per minute during sleep.

  Weekly

• Heart Rate Variability (HRV)

  Heart rate variability (HRV) is a widely recognized biomarker for autonomic nervous system regulation. Long COVID is commonly associated with reduced HRV, reflecting autonomic nervous system dysregulation. Lower HRV in these patients has been linked to greater symptom burden.

  Weekly

• Cardio Score (VO2 Max)

  Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time.

  Weekly

• SpO2

  SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.

  Weekly

• Active Zone Minutes

  Active Zone Minutes are a measure of time spent in elevated heart rate zones, including Fat Burn, Cardio, and Peak zones.

  Weekly

Other Outcomes (5)

• The Adverse and Traumatic Experiences Scale (ATES)

  Week 0

• Brain Body Center Sensory Scale (BBCSS)

  Week 0, Week 4 and Week 8

• Purpose in Life (PIL-SF)

  Week 0, Week 4 and Week 8

Study Arms (4)

Sonocea Sonic Augmentation Technology (SAT) General Wellness Product

EXPERIMENTAL

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)

Truvaga Electrical Vagus Nerve Stimulator General Wellness Product

EXPERIMENTAL

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

Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products

EXPERIMENTAL

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); Other: Truvaga Electrical Vagus Nerve Stimulator

Control (No Intervention)

NO INTERVENTION

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

Interventions

Sonocea Sonic Augmentation Technology (SAT) OTHER

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.

Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products; Sonocea Sonic Augmentation Technology (SAT) General Wellness Product

Truvaga Electrical Vagus Nerve Stimulator OTHER

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.

Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products; Truvaga Electrical Vagus Nerve Stimulator General Wellness Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Leidos Life Sciences: lead

Study Sites (1)

Virtual

Frederick, Maryland, 21703, United States

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: September 24, 2025
• Study Start: October 27, 2025
• Primary Completion: December 11, 2025
• Study Completion: December 11, 2025
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

US (1)