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Search / Trial NCT04100486

Non-Invasive Bioelectronic Analytics

Launched by NORTHWELL HEALTH · Sep 20, 2019

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Vagus Nerve Stimulation Noninvasive Autonomic Nervous System Biosensors Vitals Monitoring Machine Learning Deep Learning

ClinConnect Summary

Biomarkers that reflect disease presence or intensity, or treatment efficacy are central to medical advancements. Recorded biomarkers provide information about physiological processes regulated by the autonomic nervous system (ANS), which include blood pressure, heart rate, sweating, and body temperature. The ANS has two major divisions: sympathetic and parasympathetic systems. Most organs receive reciprocal input from both systems to achieve homeostasis through ANS balance. This regulation occurs without conscious control (i.e., autonomously). Dysregulation of the ANS can occur as the resu...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Individuals between 18-60 years of age (to avoid changes in ANS with age)
  • Individuals that are considered English Proficient due to the study requirements to follow verbal commands
  • Able-bodied persons with no known health conditions
  • BMI \< 30.0, based on height and weight (to limit known effects of high BMI on ANS activity \[Costa et al., 2019\])
  • Able and willing to give written informed consent and comply with the requirements of the study protocol
  • Exclusion Criteria:
  • History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, dementia, psychiatric illness including active psychosis, or any other chronic medical condition
  • Evidence of active infection
  • Family history of inflammatory disease
  • Treatment with an anti-cholinergic medication, including over-the-counter medications for allergy and sleep-aid within the past 1 week, including all drugs with Amitriptyline, Atropine, Benztropine, Chlorpheniramine, Chlorpromazine, Clomipramine, Clozapine, Cyclobenzaprine, Cyproheptadine, Desipramine, Dexchlorpheniramine, Dicyclomine, Diphenhydramine (Benadryl), Doxepin, Fesoterodine, Hydroxyzine, Hyoscyamine, Imipramine, Meclizine, Nortriptyline, Olanzapine, Orphenadrine, Oxybutynin, Paroxetine, Perphenazine, Prochlorperazine, Promethazine, Protriptyline, Pseudoephedrine, Scopolamine, Thioridazine, Tolterodine, Trifluoperazine, and Trimipramine
  • Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants, deep brain stimulators, or vagus nerve stimulators
  • Current tobacco or nicotine use (to limit any potentially confounding effects of exposure to nicotine), which includes any use within the past 1 week
  • Chronic inflammatory disorders
  • Pre-existing neurological disease, which indicates any significant neurological condition, including multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's Disease, or stroke
  • Pregnancy or lactation (determined by self-report), as early pregnancy may potentially impact ANS measurements
  • Active ear infection (otitis media or externa) or any other afflictions of the ear
  • Any condition that, in the investigator's opinion, would jeopardize the participant's safety following exposure to a study intervention
  • Inability to comply with study procedures and methods
  • Prisoners

About Northwell Health

Northwell Health is a leading integrated health system based in New York, dedicated to advancing healthcare through innovative research and clinical trials. With a commitment to improving patient outcomes and enhancing medical knowledge, Northwell Health conducts a diverse range of clinical studies across various therapeutic areas. The organization harnesses its extensive network of hospitals, outpatient facilities, and research institutes to facilitate cutting-edge research, ensuring access to advanced treatments for patients while fostering collaboration among healthcare professionals, researchers, and industry partners. By prioritizing patient-centric approaches and leveraging state-of-the-art technology, Northwell Health aims to drive significant advancements in medical science and public health.

Locations

Manhasset, New York, United States

Patients applied

0 patients applied

Trial Officials

Theodoros P Zanos, PhD

Principal Investigator

Northwell Health

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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