Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Tragus and Tongue Stimulation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-02

Study Completion Date

2024-01-12

Brief Summary

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this study wants to analyse the effect of trigeminal stimulation on Heart rate Variability. There are going to be two groups, in the test group it will be administered stimulation of the tongue with TENS, while in the control goup TENS will be administered at tragus level.

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Detailed Description

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This study analyses the effect of trigeminal stimulation with TENS on Heart rate variability (HRV). A new intraoral device will be administered on the dorsal surface of the tongue for TENS stimulation in the test group. The RMSSD, LF, HF and LF/HF will be monitered by photoplethysmographic wave. the results obtained with tongue stimulation will be compared with the results obtained in the control group, where it will be administered TENS stimulation at the tragus level. This work sought to assess whether there is a difference in HRV in relation to the site of application of dental ULFTENS (tragus vs tongue).

If effective in reducing the activity of arousal circuits, this tongue-level stimulation technique could have new clinical applications.

Conditions

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Arousal, Confusional

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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TUD group

an intraoral device will be administered in the TUD group in order to provide the stimulation of the dorsal surface of the tongue with dental TENS. The trial will last approximately 24 minutes, after the first 6 minutes, TENS activation will take place and how HRV values change will be evaluated. The Heart rate Variability parameters will be analysed with photopletismographic wave after 6 minutes of tongue stimulation

Group Type EXPERIMENTAL

device that stimulates the dorsal surface of the tongue

Intervention Type DEVICE

the device will be placed on the dorsal surface of the tongue. this instrument has two electrodes in turn connected to the TENS, so ultra low frequency stimulation (\<0.66 Hz) will be administered

Tragus group

patients in this group will be administered traditional trigeminal stimulation with dental TENS at tragus level. Tens will be turned on for 6 minutes in which the HRV parameters will be analyzed with the photoplethysmograph and compared with the data obtained in the TUD group.

Group Type ACTIVE_COMPARATOR

device that stimulates the tragus

Intervention Type DEVICE

two electrodes will be placed at tragus level for the administration of dental ULFTENS

Interventions

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device that stimulates the dorsal surface of the tongue

the device will be placed on the dorsal surface of the tongue. this instrument has two electrodes in turn connected to the TENS, so ultra low frequency stimulation (\<0.66 Hz) will be administered

Intervention Type DEVICE

device that stimulates the tragus

two electrodes will be placed at tragus level for the administration of dental ULFTENS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy Women
* Age 18-30 years

Exclusion Criteria

* presence of acute and/or chronic cardio-circulatory and respiratory disorders
* metabolic and autonomic system disorders
* intake of excitatory or inhibiting substances of the peripheral and central nervous system
* presence of generalised anxiety and/or panic attacks or mood disorders.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes