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NCT04100486

Non-Invasive Bioelectronic Analytics

Enrolling by Invitation
Not specifiedAges 18–60Observational
Northwell Health
~48 participants
Updated 2026-06-09 on ClinicalTrials.gov
What's tested:Standing-Squatting-Standing TestDeep Breathing TestCold Pressor TestCold Face TestValsalva ManeuverTranscutaneous Auricular Vagus Nerve Stimulation (taVNS)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Changes in Heart Rate (Electrocardiography) related to Autonomic Nervous System Perturbations
Measured over 4 2-hour sessions over 2 weeks
+6 more outcomes measured

Conditions

Autonomic Dysfunction
Autonomic Imbalance
Autonomic Nervous System Diseases
Vagus Nerve Autonomic Disorder

Explore related trials

Healthy Volunteers

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Theodoros P Zanos, PhD · PRINCIPAL_INVESTIGATOR · Northwell Health

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Changes in Heart Rate (Electrocardiography) related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    The primary objective is to measure changes in ANS balance in healthy able-bodied individuals by discovering a multi-modal index to quantify the activation status of the sympathetic and parasympathetic nervous systems during a battery of clinically relevant tasks. Changes in electrocardiography (EKG) signals will be measured to measure heart rates while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. Heart rates will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  • Changes in Brain Activity (Electroencephalography) related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    Changes in electroencephalography (EEG) signals by a dry and noninvasive electrode cap will be measured to measure brain activity while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. EEG activity will be analyzed by measuring changes in power in specific frequency bands (delta, theta, alpha, beta, and gamma). Brain activity will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  • Changes in Respiratory Rate related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    Changes in respiratory rate will be measured by a belt while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. The belt stretches and relaxes during inspiration (inhalation) and expiration (exhalation), respectively, to infer respiration rate. Respiration changes will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  • Changes in Sweat Gland Activity (Galvanic Skin Response) related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    Changes in sweat gland activity will be measured by dry metal electrodes on two fingers while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. The electrodes measure the galvanic skin response (GSR), a measure of electrical activity that changes depends on the sweat response. Sweat responses will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  • Changes in Blood Pressure related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    Changes in blood pressure will be measured by an inflatable cuff on one finger while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. A wrist device is placed with a Velcro strap on the wrist to provide air and power for the finger cuff to inflate and deflate with changes in blood pressure. Blood pressure will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  • Changes in Skin Temperature related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    Changes in skin temperature will be measured by a circular probe (smaller than a dime) placed on the skin while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. Temperature will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).

  • Changes in Pupil Size related to Autonomic Nervous System Perturbations4 2-hour sessions over 2 weeks

    Changes in pupil size will be measured by eye tracking glasses while purposefully activating the sympathetic (e.g. cold pressor test) or parasympathetic nervous systems (e.g. deep breathing) with safe, established tests to measure responses to changes in ANS function in healthy, able-bodied individuals. The glasses are easily wearable and mobile glasses with multiple small cameras to track gaze and pupil size. Pupil sizes will be assessed as percent change during tasks, with a comparison to baseline (before and after each autonomic test).