Non-Invasive Bioelectronic Analytics
Launched by NORTHWELL HEALTH · Sep 20, 2019
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Manhasset, New York, United States
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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