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Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine (CLASS-D Trial)
N/A
Waitlist Available
Led By Ben J Palanca, MD PhD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months after consent
Awards & highlights
No Placebo-Only Group
Summary
This trial will study the effects of dexmedetomidine sedation paired with CLAS conditions in repeated blocks. Stimulation will be done in-phase with EEG slow waves.
Eligible Conditions
- Sedation Complication
- Sleep
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months after consent
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after consent
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation
Difference in EEG slow wave amplitude from sham to in-phase stimulation
Difference in EEG slow wave duration from anti-phase to in-phase stimulation
+1 moreSecondary study objectives
Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session.
Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation
Difference of reactivity to thermal stimulation from sham to in-phase stimulation
+1 moreSide effects data
From 2020 Phase 4 trial • 798 Patients • NCT0200461357%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CLASS-D CohortExperimental Treatment8 Interventions
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~2810
Quantitative Sensory Testing (QST)
2019
N/A
~620
Home sleep study
2013
N/A
~320
Dexmedetomidine
2015
Completed Phase 4
~2050
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,997 Previous Clinical Trials
2,298,741 Total Patients Enrolled
Ben J Palanca, MD PhDPrincipal InvestigatorWashington University School of Medicine