Long COVID Symptoms
Conditions
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
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.
Interventions
OTHERSonocea 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.
OTHERTruvaga 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.
Sponsors
Leidos Life Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5) | Week 0, Week 4 and Week 8 | 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. |
| Body Perception Questionnaire (BPQ) | Week 0, Week 4 and Week 8 | 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. |
| Breathing Rate | Weekly | This measurement captures a user's average breaths per minute during sleep. |
| Benefits Scale | Weekly | 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. |
| Sleep Metrics | Weekly | 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. |
| Resting Heart Rate | Weekly | 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. |
| Steps | Weekly | 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. |
| Heart Rate Variability (HRV) | Weekly | 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. |
| Cardio Score (VO2 Max) | Weekly | Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time. |
| SpO2 | Weekly | SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body. |
| Active Zone Minutes | Weekly | Active Zone Minutes are a measure of time spent in elevated heart rate zones, including Fat Burn, Cardio, and Peak zones. |
| Patient Health Questionnaire-8 (PHQ-8) | Week 0, Week 4 and Week 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. |
| Generalized Anxiety Disorder-7 (GAD-7) | Week 0, Week 4 and Week 8 | 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. |
| Symptom Burden Questionnaire - Long COVID (SBQ-LC) | Week 0, Week 4 and Week 8 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Adverse and Traumatic Experiences Scale (ATES) | Week 0 | 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. |
| Sonic Augmentation Technology (SAT) Support Needs Scale | Week 0 | 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. |
| Brain Body Center Sensory Scale (BBCSS) | Week 0, Week 4 and Week 8 | The BBCSS assesses sensory processing difficulties that may reflect underlying autonomic dysfunction. |
| Purpose in Life (PIL-SF) | Week 0, Week 4 and Week 8 | The PIL-SF measures existential meaning, motivational vitality, and psychological presence. |
| Neuroception of Psychological Safety Scale (NPSS) | Week 0, Week 4 and Week 8 | The NPSS evaluates subjective experiences of social safety/co-regulation and physiological regulation. |
Countries
United States
Outcome results
None listed