What this study is
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.
What's being tested
- Standing-Squatting-Standing Test
Intervention · 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
Intervention · 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
Intervention · 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
Intervention · 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
Intervention · 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)
Intervention · 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
- Official title
- A Pilot Study to Quantify the Autonomic Nervous System Balance in Healthy, Able-Bodied Individuals
- Sponsor
- Northwell Health
- Conditions
- Autonomic Dysfunction · Autonomic Imbalance · Autonomic Nervous System Diseases · Vagus Nerve Autonomic Disorder
- Enrolling
- 48 people
- Starts
- 2019-08-29
- Est. completion
- 2025-09
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 60 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openThe Feinstein Institutes for Medical Research
Manhasset, New York, United States
Study team
Sponsor
Northwell Health
Study ID 19-0461
Principal investigator
Theodoros P Zanos, PhD
Northwell Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.