Arousal, Pupil Diameter
Conditions
Keywords
Pupil size, ULFTENS, Trigeminal electrical stimulation, tongue stimulation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)
ULFTENS device will be administered in the experimental group for 15 minutes
Sponsors
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* good health status and physical fitness * female sex * age between 20 and 30 years * non-smoker * no more than 3 espresso coffees per day * no intake of stimulant or psychotropic drugs in general * body mass index between 18.5 and 24.9
Exclusion criteria
* presence of acute and/or chronic cardiocirculatory and respiratory disorders * metabolic and autonomic system disorders * intake of peripheral and central nervous system excitatory or inhibiting substances * presence of generalized anxiety and/or panic attacks, or mood disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pupil size | 12 minutes | 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. |
Countries
Italy
Outcome results
None listed