Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

NAActive, not recruitingINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

January 20, 2021

Primary Completion Date

June 1, 2022

Study Completion Date

July 1, 2023

Conditions
SleepSedation Complication
Interventions
RADIATION

MRI

A non-contrast brain MRI will be acquired for localizing EEG slow waves

DIAGNOSTIC_TEST

Quantitative Sensory Testing (QST)

Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.

DIAGNOSTIC_TEST

Home sleep study

Unattended home sleep studies will be conducted on the night preceding sedation and on the night following sedation to assess changes in slow wave homeostasis.

OTHER

Acoustic stimulation (65db) up-slope of EEG with QST

Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves

OTHER

Acoustic stimulation (65db) down-slope of EEG with QST

65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)

OTHER

0 db with QST

sham stimulation (0 dB volume)

DRUG

Dexmedetomidine

All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml

OTHER

Breathe-Squeeze Task

All participants will be asked to perform the breathe-squeeze task throughout the experiment. This will allow us to determine loss and return of responsiveness.

Trial Locations (1)

63110

Washington University School of Medicine/Barnes-Jewish Hospital, St Louis

All Listed Sponsors
lead

Washington University School of Medicine

OTHER