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Completed

NCT Number: NCT06790459

Effects of the Ultra-low Frequencies TENS on the Arousal Circuits

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.

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Key information

Conditions

Age range

20 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dental Clinic, Mesva department

L’Aquila, Italia, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

UlfTens (Ultra-low-frequencies Transcutaneous electrical nervous stimulation)

Device

ULFTENS device will be administered in the experimental group for 15 minutes

Primary outcomes

  1. Pupil size

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

Effects of Transmucosal Electrical Tongue Stimulation (TUD) on Tonic Pupil Size in the Dark

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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