Status:
ENROLLING_BY_INVITATION
Non-Invasive Bioelectronic Analytics
Lead Sponsor:
Northwell Health
Conditions:
Autonomic Dysfunction
Autonomic Imbalance
Eligibility:
All Genders
18-60 years
Brief Summary
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 ...
Detailed Description
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...
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
Key Trial Info
Start Date :
August 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04100486
Start Date
August 29 2019
End Date
September 1 2025
Last Update
May 31 2025
Active Locations (1)
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1
The Feinstein Institutes for Medical Research
Manhasset, New York, United States, 11030