NCT06549205

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

Effects of Trigeminal Neurostimulation on Heart Rate Variability: Comparing Cutaneous (Tragus) and Tongue (Antero-Dorsal Mucosa) Stimulation.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University of L'Aquila · Academic / Other
• Sex: Female
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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.

Conditions

• Arousal, Confusional

Interventions

Type	Name	Description
DEVICE	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
DEVICE	device that stimulates the tragus	two electrodes will be placed at tragus level for the administration of dental ULFTENS

Timeline

• Start date: 2022-04-02
• Primary completion: 2023-06-24
• Completion: 2024-01-12
• First posted: 2024-08-12
• Last updated: 2024-08-12

Locations

1 site across 1 country: Italy