Arousal, Confusional
Conditions
Keywords
Trigeminal electrical stimulation, ULFTENS, Heart rate variability, tragus, tongue
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.
Interventions
DEVICEdevice 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
DEVICEdevice that stimulates the tragus
two electrodes will be placed at tragus level for the administration of dental ULFTENS
Sponsors
University of L'Aquila
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Countries
Italy
Outcome results
None listed