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

NCT06549205 | Completed

• 1 other identifier: 16137/2016
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Arousal, Confusional

Keywords

Trigeminal electrical stimulation; ULFTENS; Heart rate variability; tragus; tongue

Outcome Measures

Primary Outcomes (2)

• Changes on Low Frequency parameter (LF)

  Whether or not HRV parameter (LF) improve following tongue and tragus stimulation will be assessed by photopletismographic wave

  12 minutes

• Changes on Root mean square standard deviation (RMSSD) parameter

  Whether or not HRV parameter (RMSSD) improve following tongue and tragus stimulation will be assessed by photopletismographic wave

  12 minutes

Study Arms (2)

TUD group

EXPERIMENTAL

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

Device: device that stimulates the dorsal surface of the tongue

Tragus group

ACTIVE COMPARATOR

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.

Device: device that stimulates the tragus

Interventions

device that stimulates the dorsal surface of the tongue 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

TUD group

device that stimulates the tragus DEVICE

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

Tragus group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Women
• Age 18-30 years

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (1)

Sara Di Nicolantonio

L’Aquila, 67100, Italy

Location

Related Publications (1)

• Monaco A, Cattaneo R, Di Nicolantonio S, Strada M, Pietropaoli D, Ortu E. Effects of trigeminal neurostimulation on heart rate variability: comparing cutaneous (Tragus) and tongue (Antero-Dorsal mucosa) stimulation. BMC Oral Health. 2024 Oct 20;24(1):1257. doi: 10.1186/s12903-024-04914-2.

  PMID: 39428464 DERIVED

MeSH Terms

Conditions

Sleep Arousal Disorders

Condition Hierarchy (Ancestors)

Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 12, 2024
• Study Start: April 2, 2022
• Primary Completion: June 24, 2023
• Study Completion: January 12, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)