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

University of L'Aquila

Status: Completed

Conditions: Arousal, Confusional

Treatments: Device: device that stimulates the dorsal surface of the tongue; Device: device that stimulates the tragus

Study type: Interventional

Funder types: Other

Identifiers

NCT06549205

16137/2016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

TUD group

Experimental group

Description:

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

Treatment:

Device: device that stimulates the dorsal surface of the tongue

Tragus group

Active Comparator group

Description:

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.

Treatment:

Device: device that stimulates the tragus