Non-Invasive Bioelectronic Analytics

Enrolling by invitationOBSERVATIONAL
Enrollment

48

Participants

Timeline

Start Date

August 29, 2019

Primary Completion Date

June 30, 2025

Study Completion Date

September 30, 2025

Conditions
Autonomic DysfunctionAutonomic ImbalanceAutonomic Nervous System DiseasesVagus Nerve Autonomic Disorder
Interventions
OTHER

Standing-Squatting-Standing Test

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.

OTHER

Deep Breathing Test

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.

OTHER

Cold Pressor Test

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.

OTHER

Cold Face Test

The cold stimulus will be applied with refrigerated gel-filled compresses places on the forehead and cheeks of the participant for one minute.

OTHER

Valsalva Maneuver

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.

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)

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.

Trial Locations (1)

11030

The Feinstein Institutes for Medical Research, Manhasset

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Northwell Health

OTHER