Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549205
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Effects of Trigeminal Neurostimulation on Heart Rate Variability Comparing Tragus and Tongue Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Trigeminal Neurostimulation on Heart Rate Variability Comparing Cutaneous Tragus and Tongue Antero-Dorsal Mucosa Stimulation
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 LFHF 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
If effective in reducing the activity of arousal circuits this tongue-level stimulation technique could have new clinical applications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None