An interventional study of UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation) in Pupil Diameter and Arousal, sponsored by University of L'Aquila. Completed at 1 site in Italy. Open to female participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-24.
Sponsored by University of L'Aquila · Not applicable, Interventional, and Treatment
Pupil size is associated with the activity of the noradrenergic system, with an increase reflecting a higher state of arousal. Transmucosal electrical stimulation of the tongue could treat disorders related to dysfunctions of this system, and trigeminal stimulation through ULFTENS (TUD) has shown some positive effects. However, no studies have examined the effect of stimulation of the anterior mucosa of the tongue on pupil size as an indicator of arousal. The aim of this study will be to evaluate the effect of ULFTENS stimulation on pupil size in the dark.
Changes in pupil size are indicative of the activity of the noradrenergic system, with pupil dilation associated with a higher state of arousal. According to various studies, odontological ULFTENS, through trigeminal stimulation, can help rebalance this altered system with positive effects. Our goal is to harness the capabilities of ULFTENS by stimulating the dorsal lingual mucosa and evaluating its effects on pupil size in the dark. Healthy women aged between 20 and 30 will be recruited and divided into two groups: a control group and an experimental group. Participants in the control group will lie down on a bed with their eyes closed, and will then be asked to open their eyes without moving their eyelids. Pupil diameter will be measured using a pupillometer for 15 seconds. This procedure will be repeated twice. The experimental group will receive a tongue stimulator connected to the ULFTENS, which will be activated after the first measurement. The stimulation will last approximately 15 minutes, with a second measurement taken after 15 seconds. At the end of the stimulation, the final measurement will be taken. The goal is to measure the pupil diameter of both eyes at the three time points and compare the results between the two groups to assess the effect of the stimulator on arousal circuits.
University of L'Aquila is the lead sponsor of 45 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
20 women of 20-30 years would be enrolled to the experimental group. They will undergone to tongue stimulation with ULFTENS device for 15 minutes. Pupils' diameter will be measure for three time points, before, during and after the tongue stimulation
Device: UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)
20 women of 20-30 years will be enrolled to the control group. Their pupils' diameter will be measure at three time points
ULFTENS device will be administered in the experimental group for 15 minutes
Pupil size
left and right pupils diameter will be measured using a pupillometry. Images of the pupils will be acquired by the Oculus system, using two infrared CCD cameras (resolution 720 × 576 pixels, 256 grey levels) mounted on a light helmet (1.5 kg), with sampling frequency of 25 frame/s. The eyes will be illuminated with an infrared diode with 880 nm of wave length.
Time frame: 12 minutes
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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University of L'Aquila