Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06386809
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-26
First Post:
2024-04-22
Brief Title:
Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism
Sponsor:
Bandırma Onyedi Eylül University
Organization:
Bandırma Onyedi Eylül University
Study Overview
Official Title:
Investigation of the Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation in Bruxism- Randomised Controlled Single Blinded Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Our study aimed to investigate the effects of transcutaneous auricular vagus nerve stimulation TAVNS application on treatment efficacy in bruxism in terms of masseter muscle activity pain stress level sleep and life quality and autonomic functions
Detailed Description:
Our study was designed as a randomized single-blind experimental clinical trial It was planned to include 40 individuals diagnosed with bruxism in our research Outcome measurements and assessments will be performed immediately after the participants are recruited and at the end of the 8-week program Pain intensity oral health quality of life stress level and sleep quality will be assessed by self-report through questionnaires Pressure pain threshold and muscle activation for the masseter muscle and heart rate variables measurements will be performed by physiotherapists After completing the initial evaluations the participants will be randomly divided into two groups An eight-week exercise program will be applied to the control group In the TAVNS group in addition to the eight-week exercise program TAVNS will be used twice weekly for 16 sessions with the VAGUSTIM device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None