Open Impact of Vagal Approaches on Symptomatology in Long COVID Participants [Remote]

[Jaybee00]

Survivor Corps is advocating with you to better understand COVID-19 and Long COVID through citizen science, research, legislation and policy.

Calling All Citizen Scientists!

Join a 4-week Study Exploring Wellness Products for Long COVID Symptoms. Join ASAP!

We’re inviting individuals with Long COVID (symptoms persisting over three months after an acute Covid infection) to partner with us in a fully virtual 4-week study exploring whether two general wellness tools can support individuals experiencing Long COVID.

Because the study is entirely remote, you can participate from the comfort of your home using a smartphone.

The wellness tools in this study are designed to gently stimulate the vagus nerve, which plays a key role in managing stress, relaxation, mood, breathing, heart rate, inflammation, and digestion — areas often affected by Long COVID.

Participants in the Wellness Study will be randomly assigned to one of four groups:

● A group using sound-based technology, delivered through a smartphone app and headphones

● A group using a handheld vagus nerve stimulator, for a brief period each day

● A group using both tools together

● A control group that will track symptoms without any intervention, helping researchers better understand symptom patterns over time

All participants will receive a Fitbit to track physiological data—and it’s yours to keep!
If you’re assigned to the stimulator group, you’ll also keep that device.

Everyone who completes all study surveys, regardless of cohort, will receive a $100 gift card as a thank-you at the end of the study.

HOW TO JOIN:
Step 1: Enroll in the Long COVID Research Repository— a simple one-time sign-up to share your background and symptoms. This first survey takes no more than 20 minutes.

Step 2: Once enrolled in the Repository, you will be able to sign up for the Wellness Study.

Step 3: Over the 4-week study, you’ll complete brief weekly check-ins (each less than 10 minutes), as well as surveys at the beginning and end of the study.

We understand how limited energy and focus can be with Long COVID, so we’ve designed this study to be low-effort, flexible, and fully remote. Your contribution to studies like this one is essential to shaping tools that could potentially benefit other Long COVID patients as well as inform the scientific community working to understand the condition. Thank you.

Ready to get started? Click HERE.

 

[Jaybee00]

Rocky Vista University Is a for profit university

 

[Hutan]

Link to the study entry on the Clinical Trials registry

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.
Official Title: Impact of Vagal Approaches on Symptomatology in Long COVID Participants
Conditions: Long COVID Symptoms

Intervention / Treatment

• Other: Sonocea Sonic Augmentation Technology (SAT)
• Other: Truvaga Electrical Vagus Nerve Stimulator

 

[Hutan]

This looks terrible, quite apart from the open label design and volunteer participant selection.

There are 14 primary outcomes, including a measure of major depressive disorder, a measure of generalised anxiety disorder, a measure of PTSD, something called a Body Perception Questionnaire, and something called the 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.

There are 5 secondary outcomes which look uniformly awful.

Any prospective participants need to think carefully about whether they want to give all of that information to the investigators and whoever else gets access to the data.

 

[Hutan]

I don't understand why Survivor Corps would be promoting this study. Does anyone have connections to them, to warn them that this study is a p-hacking highly biased expressway to a positive result for commercial products and fodder for patient-blaming?

 

[Hutan]

Leidos Life Sciences is owned by Leidos Holdings:

Leidos Holdings, Inc. is an American defense, aviation, information technology, and biomedical research company headquartered in Reston, Virginia, that provides scientific, engineering, systems integration, and technical services. Founded as Science Applications International Corporation (SAIC),Leidos merged with Lockheed Martin's IT sector, Information Systems & Global Solutions (Lockheed Martin IS&GS), in August 2016 to create the defense industry’s largest IT services provider. The Leidos-Lockheed Martin merger is one of the biggest transactions thus far in the consolidation of the defense sector. Leidos contracts extensively with the Department of Defense, the Department of Homeland Security, and the Intelligence Community, as well as other U.S. government agencies and select commercial markets.

Sonocea Sonic Augmentation Technology
"Auditory Entrainment: Carefully designed rhythmic sound patterns engage the brainstem, guiding the body out of stress and into a state of restoration."


Truvaga
"Welcome your new personal wellness companion. Meet Truvaga Plus, our latest handheld vagus nerve stimulator, designed with extra features to elevate your stress-relief journey. This sleek and portable design has everything you need to live a healthier life – quickly, easily, and conveniently."
"94% of users felt calmer and happier in just 30 days*"


From the Patient Information Sheet:

Confidentiality
When you take part in research, you might lose some privacy, but the researchers will do their best to keep your information private (see below). To keep your privacy, we will not ask for your birthday or social security number. We will only collect information that is critical for the study such as your medication use and medical history. Your private information won't be used in any reports or presentations from this study.

We will get your information from your survey answers. This information will be kept safe in a special folder on a secure, password-protected online storage system. There will be no paper copies. Also, your name will be taken off and your information will be given a random Participant ID number before we look at it.

The survey answers you provide could be used for future research or given to another researcher without asking for your permission again.