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

Not Applicable

Completed

• Conditions: Arousal, Confusional
• Interventions: Device: device that stimulates the tragus; Device: device that stimulates the dorsal surface of the tongue

• Registration Number: NCT06549205
• Lead Sponsor: University of L'Aquila

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-04-02
• Primary Completion: 2023-06-24
• Study Completion: 2024-01-12
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-07
• Last Update Submitted: 2024-08-07
• Study First Posted: 2024-08-12
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tragus group	device that stimulates the tragus	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.
TUD group	device that stimulates the dorsal surface of the tongue	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

Primary Outcome Measures

Name	Time	Method
Changes on Root mean square standard deviation (RMSSD) parameter	12 minutes	Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave
Changes on Low Frequency parameter (LF)	12 minutes	Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave

Trial Locations

Locations (1)

Sara Di Nicolantonio; 🇮🇹 L'Aquila, Italy