Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine (CLASS-D)

April 13, 2026 updated by: Ben J.A. Palanca, Washington University School of Medicine
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine/Barnes-Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18-40 years
  • Healthy volunteers (American Society of Anesthesiologists Physical Status 1-2).

Exclusion Criteria:

  • Diagnosed sleep disorders
  • Habitually short sleepers
  • Diagnosed psychiatric disorders
  • Use of psychoactive medication (e.g., antidepressants, mood stabilizers or antipsychotics), diagnosed hearing disorder
  • Neck circumference > 40 cm
  • Body Mass Index > 30
  • Acknowledged recreational drug or nicotine use
  • Resting heart rate during slow wave sleep < 40 beats per minute
  • Pregnancy or nursing
  • Persistently inconsistent or elevated QST heat pain tolerance thresholds (>50 ºC).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: CLASS-D Cohort - In-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation
Radiation: MRI
A non-contrast brain MRI will be acquired for localizing EEG slow waves
Other Names:
  • Structural magnetic resonance imaging
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.
Other Names:
  • Quantitative Sensory Testing
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 Names:
  • Unattended polysomnography
Drug: Dexmedetomidine
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
Other Names:
  • Dexmedetomidine hydrochloride
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.
Other Names:
  • Internally directed behavioral task
Other: Acoustic stimulation (65 decibels or db) up-slope of EEG with QST
Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves
Other Names:
  • In-phase CLAS with sensory testing
Active Comparator: CLASS-D Cohort - Anti-phase
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation
Radiation: MRI
A non-contrast brain MRI will be acquired for localizing EEG slow waves
Other Names:
  • Structural magnetic resonance imaging
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.
Other Names:
  • Quantitative Sensory Testing
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 Names:
  • Unattended polysomnography
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 Names:
  • Anti-phase CLAS with sensory testing
Drug: Dexmedetomidine
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
Other Names:
  • Dexmedetomidine hydrochloride
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.
Other Names:
  • Internally directed behavioral task
Sham Comparator: CLASS-D Cohort - Sham
Within-subject crossover cohort with intervention, acoustic stimulation anticipated in phase with the anticipated peak of EEG slow wave oscillation but no acoustic stimulation delivered.
Radiation: MRI
A non-contrast brain MRI will be acquired for localizing EEG slow waves
Other Names:
  • Structural magnetic resonance imaging
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.
Other Names:
  • Quantitative Sensory Testing
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 Names:
  • Unattended polysomnography
Other: 0 db with QST
sham stimulation (0 dB volume)
Other Names:
  • Sham CLAS with sensory testing
Drug: Dexmedetomidine
All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
Other Names:
  • Dexmedetomidine hydrochloride
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.
Other Names:
  • Internally directed behavioral task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation
Time Frame: Sham stimulation and in-phase stimulation blocks during the intervention
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both sham and in-phase blocks.
Sham stimulation and in-phase stimulation blocks during the intervention
Difference in EEG Slow Wave Activity From Anti-phase to In-phase Stimulation
Time Frame: Anti-phase and in-phase blocks during the intervention
EEG slow waves activity (power) relative to the timing of the stimulation. Values are log-transformed All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Anti-phase and in-phase blocks during the intervention
Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation
Time Frame: anti-phase and in-phase blocks during the intervention
Difference in EEG slow wave density from anti-phase to in-phase stimulation by looking at EEG slow waves duration relative to the timing of the stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
anti-phase and in-phase blocks during the intervention
Difference in EEG Slow Wave Density From Sham to In-phase Stimulation
Time Frame: Sham stimulation and in-phase stimulation blocks during the intervention
Difference in EEG slow wave density from sham to in-phase stimulation by looking at EEG slow waves relative to the timing of the stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
Sham stimulation and in-phase stimulation blocks during the intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation
Time Frame: Anti-phase and in-phase blocks of the intervention
Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation by measuring the threshold for responsiveness to thermal stimulation All participants serve in the same arm but experience both anti-phase and in-phase blocks.
Anti-phase and in-phase blocks of the intervention
Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation
Time Frame: Sham and in-phase blocks during intervention
Difference of reactivity to thermal stimulation from sham to in-phase stimulation by measuring the threshold for responsiveness to thermal stimulation All participants serve in the same arm but experience both sham and in-phase blocks.
Sham and in-phase blocks during intervention
Slow Wave Activity Calculated During N3 Sleep
Time Frame: on the nights before and the night of the intervention
Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session. Calculated as power
on the nights before and the night of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ben J Palanca, MD PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 20, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201907086

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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