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Completed
NCT07856459
ABVN Phase 2 - EDS Wearable Device
Conditions: Ehlers-Danlos Syndrome, Healthy Subjects
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 58
Sponsor: Indiana University
Location: Indiana University Indianapolis Indiana
Summary
The vagus nerve is a nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this may lead to additional treatment options for patients with nausea and vomiting and disordered stomach function.
The overall purpose of the ABVN Phase 2 grant is to expand on previous work evaluating the effects of noninvasive stimulation on vagal nerve function. This will be accomplished through several independent, but related, studies. In this study, investigators will evaluate autonomic responses in Ehlers-Danlos Syndrome patients and healthy participants during transcutaneous electrical stimulation of the vagus nerve and during normal daily activities.
Eligibility Criteria
Inclusion Criteria healthy volunteers
* Healthy volunteers with no major medical conditions including heart disease, lung disease, cancer, EDS or GI disease
* Aged 18-80 years
* Willing to have electrodes placed in the external ear
* Willing to wear the watch for 4 weeks continuously
Exclusion Criteria healthy volunteers:
* Unable to provide consent
* Pregnant females
* Prisoners
Inclusion Criteria EDS subjects:
* Have a formal diagnosis of EDS
* Aged 18-80 years
* Willing to have electrodes placed in the external ear
* Willing to wear the watch for 4 weeks continuously
Exclusion Criteria for EDS subjects:
* Unable to provide consent
* Not having a diagnosis of EDS
* Pregnant females
* Prisoners
Source: ClinicalTrials.gov (NCT07856459). StuddyBuddy aggregates publicly available trial information.