← Back to Search

Dexmedetomidine for Sedation Complication (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

CLASS-D Trial 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

CLASS-D Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months after consent
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months after consent for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
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

CLASS-D 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
~1370
Home sleep study
2013
N/A
~320
Quantitative Sensory Testing (QST)
2019
N/A
~620
Dexmedetomidine
2015
Completed Phase 4
~1980

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,689 Total Patients Enrolled
Ben J Palanca, MD PhDPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is the ideal demographic for this research protocol?

"In order to be considered for this medical trial, applicants must have experienced sedation-related issues and fall within the 18-40 age bracket. This study is seeking approximately 20 participants."

Answered by AI

Can you provide an overview of any prior research conducted with Dexmedetomidine?

"Currently, 23 Phase 3 trials for Dexmedetomidine are active across 204 clinical sites worldwide. Most of these studies originate in Karachi, Sindh province alone."

Answered by AI

In what medical scenarios is Dexmedetomidine most commonly prescribed?

"Dexmedetomidine is the typical intervention for this malady, but it may also be beneficial in cases of ventilation distress, mechanical obstruction, cyclic vomiting syndrome and intubations."

Answered by AI

What are the most important goals of this trial?

"The primary outcome of this trial, to be evaluated up to 3 months post-consent, is the divergence between EEG slow wave duration from a placebo and in-phase stimulation. Secondary effects being measured include the sensitivity threshold for thermal stimuli when comparing sham and in-phase treatments as well as anti-phase and in-phase therapies; changes in nocturnal slow wave activity will also be assessed against levels prior to study sessions."

Answered by AI

What is the enrollment capacity for this research program?

"At this moment in time, participation for the aforementioned study is not being actively sought. Originally posted on January 20th 2021 and last updated November 29th 2022, if you are interested in other trials there exist 150 sedation complication studies and 108 Dexmedetomidine clinicals recruiting patients currently."

Answered by AI

Is the age range for patient recruitment confined to those above 35 years?

"The minimum age requirement for entry into this trial is 18 years old, while the maximum allowable age is 40."

Answered by AI

Is this research still open to recruitment?

"This clinical trial is now closed for recruitment and has been since November 29th, 2022. If you are seeking other medical studies to participate in, there currently 150 experiments searching for patients dealing with sedation complications and 108 trials using Dexmedetomidine that are actively recruiting participants."

Answered by AI
~5 spots leftby Apr 2025