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Completed

NCT Number: NCT06549205

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

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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Key information

Conditions

Arousal, Confusional Mental Disorders Nervous System Diseases Parasomnias Sleep Arousal Disorders Sleep Wake Disorders

Age range

18 year–30 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sara Di Nicolantonio

L’Aquila, 67100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

device that stimulates the tragus

Device

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

Primary outcomes

  1. Changes on Low Frequency parameter (LF)

    Time frame: 12 minutes

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

  2. Changes on Root mean square standard deviation (RMSSD) parameter

    Time frame: 12 minutes

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

Sponsors and collaborators

Lead sponsor

University of L'Aquila

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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