At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
In Brief
A clinical study evaluating MRI, Quantitative Sensory Testing (QST), and 6 other interventions for Sleep and Sedation Complication. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A non-contrast brain MRI will be acquired for localizing EEG slow waves
Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.
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.
Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves
65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
sham stimulation (0 dB volume)
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
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.