An interventional study of Sonocea Sonic Augmentation Technology (SAT) and Truvaga Electrical Vagus Nerve Stimulator in Long COVID Symptoms, sponsored by Leidos Life Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Leidos Life Sciences · Not applicable, Interventional, and Other
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.
520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.
This study's enrollment of 546 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.
Browse Post-Acute COVID-19 Syndrome studies →Leidos Life Sciences is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Self-identified as having Long COVID based on symptomology:
a. Symptoms must include any combination of the following: (ICD-10 codes shown):
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)
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
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
Participants enrolled in this arm will not use either wellness product.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Weekly
Breathing Rate
This measurement captures a user's average breaths per minute during sleep.
Time frame: 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.
Time frame: 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.
Time frame: Weekly
SpO2
SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.
Time frame: 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.
Time frame: Weekly
The Adverse and Traumatic Experiences Scale (ATES)
ATES captures developmental and lifetime adversity that may impact vagal tone and neuroception. The ATES will allow us to examine the effectiveness of SAT and the Electrical Vagus Nerve Stimulator in individuals who report being impacted by their adversity histories.
Time frame: Week 0
Brain Body Center Sensory Scale (BBCSS)
The BBCSS assesses sensory processing difficulties that may reflect underlying autonomic dysfunction.
Time frame: Week 0, Week 4 and Week 8
Purpose in Life (PIL-SF)
The PIL-SF measures existential meaning, motivational vitality, and psychological presence.
Time frame: Week 0, Week 4 and Week 8
Neuroception of Psychological Safety Scale (NPSS)
The NPSS evaluates subjective experiences of social safety/co-regulation and physiological regulation.
Time frame: Week 0, Week 4 and Week 8
Sonic Augmentation Technology (SAT) Support Needs Scale
This tool enables tailored interpretation of individual differences in responsivity to Sonic Augmentation Technology and vagus nerve stimulation, particularly in populations with heightened neurophysiological sensitivity or neurodivergent traits.
Time frame: Week 0
Plan to share: Undecided — Results from the study will be analyzed and reported in accordance with the protocol and applicable regulations. Additionally, findings may be shared in presentations, publications, or other formats as determined by the study team and stakeholders.
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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