Long COVID SymptomsNCT07190105
Vagal Approaches on Long COVID-19
A study testing Sonocea Sonic Augmentation Technology (SAT) and Truvaga Electrical Vagus Nerve Stimulator in people with Long COVID Symptoms, run by Leidos Life Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long COVID Symptoms
- What is being tested?
- Sonocea Sonic Augmentation Technology (SAT) and Truvaga Electrical Vagus Nerve Stimulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2025to 11 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Symptoms must include any combination of the following: (ICD-10 codes shown):
- Shortness of breath (R06.02, R06.00, or R06.09)
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Vagal Approaches on Symptomatology in Long COVID Participants
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
- Being tested
- Sonocea Sonic Augmentation Technology (SAT), Truvaga Electrical Vagus Nerve Stimulator
- 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
- Medical subject headings
- Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Truvaga Electrical Vagus Nerve StimulatorOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Weekly
Breathing Rate
This measurement captures a user's average breaths per minute during sleep.
Measured: 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.
Measured: 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.
Measured: Weekly
SpO2
SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.
Measured: 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.
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start27 Oct 2025
- Primary completion11 Dec 2025
- Study completion11 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 546 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leidos Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07190105
- Sponsor's protocol ID
- LDOS-25-001
- Other IDs
- MCDC2015-003
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vagal Approaches on Symptomatology in Long COVID Participants
- ClinicalTrials.gov ID
- NCT07190105
- Acronym / sponsor ID
- LDOS-25-001
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Leidos Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Dec 2025 (actual)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sonocea Sonic Augmentation Technology (SAT) General Wellness Product | Experimental | Other: Sonocea Sonic Augmentation Technology (SAT)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. |
| Truvaga Electrical Vagus Nerve Stimulator General Wellness Product | Experimental | Other: Truvaga Electrical Vagus Nerve StimulatorParticipants 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. |
| Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products | Experimental | Other: Sonocea Sonic Augmentation Technology (SAT), Other: Truvaga Electrical Vagus Nerve StimulatorParticipants enrolled in this arm will use both the Sonocea SAT and Truvaga Electrical Vagus Nerve Stimulator general wellness products. |
| Control (No Intervention) | No intervention | –Participants enrolled in this arm will not use either wellness product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- Participants must have auditory headphones; over the ear headphones or earbuds
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonocea 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. | Other | Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products, Sonocea Sonic Augmentation Technology (SAT) General Wellness Product |
| Truvaga Electrical Vagus Nerve StimulatorThe 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. | Other | Sonocea SAT + Truvaga Electrical Vagus Nerve Stimulator General Wellness Products, Truvaga Electrical Vagus Nerve Stimulator General Wellness Product |
Primary outcome
Patient Health Questionnaire-8 (PHQ-8)
Time frame: 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)
Time frame: 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.
PTSD Checklist for DSM-5 Short Form (Abbreviated PCL-5)
Time frame: 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.
Symptom Burden Questionnaire - Long COVID (SBQ-LC)
Time frame: 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.
Body Perception Questionnaire (BPQ)
Time frame: 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.
Benefits Scale
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Breathing Rate
Time frame: Weekly
This measurement captures a user's average breaths per minute during sleep.
Heart Rate Variability (HRV)
Time frame: 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)
Time frame: Weekly
Tracking changes in estimated aerobic capacity can help evaluate whether approaches are improving cardiovascular function and exercise tolerance over time.
SpO2
Time frame: Weekly
SpO2 measures blood oxygen saturation levels, indicating how well oxygen is being transported throughout the body.
Active Zone Minutes
Time frame: Weekly
Active Zone Minutes are a measure of time spent in elevated heart rate zones, including Fat Burn, Cardio, and Peak zones.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: 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.
Related trials for Long COVID Symptoms
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonocea Sonic Augmentation Technology (SAT) and Truvaga Electrical Vagus Nerve Stimulator in people with Long COVID Symptoms, run by Leidos Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-8 (PHQ-8) (time frame: Week 0, Week 4 and Week 8). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.