Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341413
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-03-26
Brief Title:
Sleep and Emotion Processing in Adolescent Post-traumatic Stress Disorder
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Sleep and Emotion Processing in Adolescent Post-Traumatic Stress Disorder
Status:
RECRUITING
Status Verified Date:
2024-08
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:
The goal of this clinical trial is to characterize the role of sleep emotion processing and daily affect in post-traumatic stress disorder PTSD and whether improving sleep quality using slow wave activity enhancement will impact next-day affect in youth
Participants will attend 4 study visits
A clinical and trauma assessment visit
A testing day that may include cognitive testing surveys and an MRI
An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition
Participants will attend 4 study visits
A clinical and trauma assessment visit
A testing day that may include cognitive testing surveys and an MRI
An overnight sleep study following one week of at-home sleep recordings with the device in the sham condition
An overnight sleep study following one week of at-home sleep recordings with the device in the sleep enhancement condition
Detailed Description:
In this study researchers aim to characterize sleep and explore its relationship to emotion processing and daily affect in 165 youth spilt into 3 groups Researchers will use advanced sleep assessment methodologies including 1 high-density EEG 256 channels in the laboratory to explore the regional distribution of sleep before and after an emotional learning task and 2 a sleep-wearable EEG recording headband SmartSleep to record sleep longitudinally at home Using SmartSleeps sleep enhancement algorithms researchers will determine whether the deepest sleep slow-wave activity SWA of non-rapid eye-movement NREM sleep can be reliably increased in all youth
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| A539500 | OTHER | None | None |
| SMPHSLEEP CENTERSLEEP CTR | OTHER | None | None |
| Protocol version 5152024 | OTHER | None | None |
| 1R01MH132221 | NIH | UW- Madison | httpsreporternihgovquickSearch1R01MH132221 |