Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT04206059
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-12-02
First Post:
2019-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2022-11
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:
CLASS-D
Brief Summary:
Prospective within-subject study of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Intervention will consist of CLAS in-phase with EEG slow waves. Anti-phase stimulation will serve as an active control while sham stimulation will serve as a passive control.
Detailed Description:
Both nonpharmacologic and pharmacologic interventions augment expression of EEG slow waves that mimic those of natural sleep. Closed loop auditory stimulation (CLAS) is a noninvasive inexpensive approach to augment the spectral power and duration of these slow waves. Whether in-phase CLAS may address this need is unknown, since acoustic potentiation of pharmacologically-induced slow waves has not been investigated. This prospective within-subject study of dexmedetomidine sedation paired with CLAS will assess the feasibility of augmenting EEG slow waves during sedation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: