Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614803
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Study of the Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Regulatory Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia and Its Impact on Interoceptive Indicators
Status:
COMPLETED
Status Verified Date:
2024-09
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:
The study recruited college students with insomnia disorders and applied transcutaneous auricular vagus nerve stimulationtaVNS combined with slow breathing The main aims of the study are 1 to explore the role of this novel and effective physical therapy technique of taVNS combined with slow breathing in regulating insomnia 2 to investigate the relationship between the synergistic effect of taVNS and slow breathing on interoceptive indicators and their therapeutic effects
Detailed Description:
This study conducted a randomized controlled clinical trial with an intention to enroll 80 insomnia participants Participants were randomly assigned in a 1111 ratio to four groups1taVNS combined with slow breathing group2taVNS with normal breathing group3slow breathing with sham taVNS group4normal breathing with sham taVNS groupThe study included a one-week baseline period a two-week treatment period and a two-week follow-up period During the 2-week treatment period 20 minutes of continuous treatment was performed every evening The stimulation parameters were set to 20Hz 200μs 5s ON-5s OFF and a burst frequency of 2000Hz For taVNS combined with slow breathing groupafter preparing the skin electrodes were attached to the tragus and cymba conchae of the left earand under the guidance of the device39s video the participants were instructed to perform six slow and relaxed breaths per minute 01Hz while the device delivered stimulation during the 5 seconds of exhalationFor taVNS with normal breathing groupwithout video guidance on the device the participants breathed freely while receiving normal taVNS interventionFor slow breathing with sham taVNS groupthe participants followed the video instructions to perform slow breathing while wearing the stimulation electrodes but the device only outputted stimulation for one minuteFor normal breathing with sham taVNS groupthe device outputted stimulation for only one minute and the participants breathed normally EEG and ECG data were collected before and after the 2-week treatment and scale data were collected before and after the treatment as well as at the end of follow-up Sleep diaries were recorded throughout the 5-week period
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