Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547086
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation
Status:
RECRUITING
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 goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in emotional health and stress resilience
Participants will attend up to 3 study visits each of which may last up to 4-5 hours During these visits participants will wear a high density electroencephalography hdEEG cap and take a nap
Participants will attend up to 3 study visits each of which may last up to 4-5 hours During these visits participants will wear a high density electroencephalography hdEEG cap and take a nap
Detailed Description:
This is a single-blind two-phase study In the first phase each participant will be assigned a nap length a trigger region a stimulation type difference frequency multipolar transcranial electrical stimulation with temporal interference TES-TI or phase modulation and a stimulation start time relative to the appearance of spindles and sawtooth waves in their EEG These parameters will be varied across and within participants who may undergo multiple naps in order to identify optimal parameters for enhancing REM sleep
Phase II is a single-blind study comprised of 24 participants Each participant will undergo two 90-minute naps with possible sham or non-sham stimulation conditions The naps will be on 2 separate visits to the lab with at least 1 week between visits Conditions on each visit are randomized and counterbalanced During each visit participants will complete both the REST-Q and SSS questionnaires Full HDEEG will be applied as well as 4-16 stimulation electrodes Participants will then undergo an emotion regulation task face task wherein they are presented with positive negative or neutral emotional stimuli This is followed by a resting EEG recording then a nap up to 90 minutes in duration Either sham or non-sham stimuli will be applied at times during the nap period Upon waking the same questionnaires and emotion regulation tasks will be completed
Phase II is a single-blind study comprised of 24 participants Each participant will undergo two 90-minute naps with possible sham or non-sham stimulation conditions The naps will be on 2 separate visits to the lab with at least 1 week between visits Conditions on each visit are randomized and counterbalanced During each visit participants will complete both the REST-Q and SSS questionnaires Full HDEEG will be applied as well as 4-16 stimulation electrodes Participants will then undergo an emotion regulation task face task wherein they are presented with positive negative or neutral emotional stimuli This is followed by a resting EEG recording then a nap up to 90 minutes in duration Either sham or non-sham stimuli will be applied at times during the nap period Upon waking the same questionnaires and emotion regulation tasks will be completed
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