Non-Invasive Bioelectronic Analytics

Part of paid clinical trials in Manhasset, New York.

Sponsor
Northwell Health
Study ID
NCT04100486
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Standing-Squatting-Standing Test — OTHER
    The participant will begin by actively standing for one minute, followed by a transition to a squat for one minute, and one last transition to one minute of standing.
  • Deep Breathing Test — OTHER
    The participant will be asked to lay down for seven minutes and take long, controlled breaths at a rate within 4 to 10 breaths per minute.
  • Cold Pressor Test — OTHER
    The participant will be asked to immerse their hand into ice water (1- 10°C) for up to three minutes, followed by removal of the hand from the bath and continuation for recording for a further three to five minutes. The participant will be informed that he or she can remove his or her hand at any point if there is discomfort.
  • Cold Face Test — OTHER
    The cold stimulus will be applied with refrigerated gel-filled compresses places on the forehead and cheeks of the participant for one minute.
  • Valsalva Maneuver — OTHER
    The participant will be asked to inhale deeply, pinch his or her nose, close his or her mouth, and forcibly exhale, while bearing down with tight chest and stomach muscles, for approximately 10 to 15 seconds. The sensors will continue recording as the participant recovers to normal breathing over the next one minute.
  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) — DEVICE
    The participant will receive electrical stimulation applied to their ear for five minutes. The threshold for stimulation will be determined before the test begins at a level that may elicit sensation (tickling, vibrating, pricking), but no pain. There is a possibility that the participant will receive sham stimulation, or inactive stimulation, for this test.

Study Details

Biomarkers can be evaluated to provide information about disease presence or intensity and treatment efficacy. By recording these biomarkers through noninvasive clinical techniques, it is possible to gain information about the autonomic nervous system (ANS), which involuntarily regulates and adapts organ systems in the body. Machine learning and signal processing methods have made it possible to quantify the behavior of the ANS by statistically analyzing recorded signals. This work will aim to systematically measure ANS function by multiple modalities and use decoding algorithms to derive an index that reflects overall ANS function and/or balance in healthy able-bodied individuals. Additionally, this study will determine how transcutaneous auricular vagus nerve stimulation (taVNS), a noninvasive method of stimulating the vagus nerve without surgery, affects the ANS function. Data from this research will enable the possibility of detecting early and significant changes in ANS from "normal" homeostasis to diagnose disease onset and assess severity to improve treatment protocols.

Key Dates

Start date
Aug 29, 2019
Status verified
Jun 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
48 participants (estimated)

Arms

  • Arm: Healthy, Able-Bodied Individuals
    This study will only enroll healthy, able-bodied individuals.

Primary Outcome Measure

Changes in Heart Rate (Electrocardiography) related to Autonomic Nervous System Perturbations [ Time Frame: 4 2-hour sessions over 2 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Feinstein Institutes for Medical ResearchManhassetNew York11030-

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The Feinstein Institutes for Medical Research· Manhasset, NY

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