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临床试验/NCT06790459
NCT06790459已完成不适用

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

University of L'Aquila2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年9月24日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Pupil size

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Pupil size

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Di Nicolantonio

PhD candidate

University of L'Aquila

研究点 (2)

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