Non-Invasive Bioelectronic Analytics

Launched by NORTHWELL HEALTH · Sep 20, 2019

Keywords

ClinConnect Summary

This is a small, early-phase study at The Feinstein Institutes (Northwell Health) to learn how the autonomic nervous system—our body’s automatic control of heart rate, breathing, sweating, pupil size, and more—works in healthy adults. Researchers will have about 48 volunteers complete four 2-hour sessions over two weeks. During these visits, you’ll perform simple tests (like standing-squatting, deep breathing, a cold-water hand test, a brief cold face stimulus, and a Valsalva maneuver) while noninvasively monitoring your heart, brain waves, breathing, sweating, blood pressure, skin temperature, and eye pupil size. In one part of the study they’ll also test a noninvasive ear-based vagus nerve stimulator (taVNS) to see if it changes these measurements. The goal is to develop a safe, noninvasive way to quantify overall autonomic balance using signals from multiple sensors and computer analysis.

To join, you’d need to be 18–60 years old, in generally good health, with a body mass index (BMI) under 30, and able to understand English. People with certain medical conditions, pregnancy, ear problems, active smoking, implanted electronic devices, or other factors described in the study criteria would not be eligible. The study is designed for healthy volunteers and aims to create biomarkers that could help detect early changes in autonomic function and inform future therapies. If this sounds like something you’d consider, talk with your clinician about whether a study like this might fit your interests and health.

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