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

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ClinicalTrials.gov Identifier: NCT04206059
Recruitment Status : Active, not recruiting
First Posted : December 20, 2019
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Ben J.A. Palanca, Washington University School of Medicine

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Sleep Sedation Complication Radiation: MRI Diagnostic Test: Quantitative Sensory Testing (QST) Diagnostic Test: Home sleep study Other: Acoustic stimulation (65db) up-slope of EEG with QST Other: Acoustic stimulation (65db) down-slope of EEG with QST Other: 0 db with QST Drug: Dexmedetomidine Other: Breathe-Squeeze Task Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine
Actual Study Start Date : January 20, 2021
Actual Primary Completion Date : June 1, 2022
Estimated Study Completion Date : July 1, 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: CLASS-D Cohort
Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation, and 0 dB stimulation.
 Radiation: MRI
A non-contrast brain MRI will be acquired for localizing EEG slow waves
Other Name: 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 Name: 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 Name: Unattended polysomnography

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 Name: In-phase CLAS with sensory testing

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 Name: Anti-phase CLAS with sensory testing

Other: 0 db with QST
sham stimulation (0 dB volume)
Other Name: 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 Name: 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 Name: Internally directed behavioral task


Outcome Measures
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Primary Outcome Measures :
  1. Difference in EEG slow wave amplitude from sham to in-phase stimulation [ Time Frame: up to 3 months after consent ]
    EEG slow waves amplitude relative to the timing of the stimulation

  2. Difference in EEG slow wave duration from sham to in-phase stimulation [ Time Frame: up to 3 months after consent ]
    EEG slow waves duration relative to the timing of the stimulation

  3. Difference in EEG slow wave amplitude from anti-phase to in-phase stimulation [ Time Frame: up to 3 months after consent ]
    EEG slow waves amplitude relative to the timing of the stimulation

  4. Difference in EEG slow wave duration from anti-phase to in-phase stimulation [ Time Frame: up to 3 months after consent ]
    EEG slow waves duration relative to the timing of the stimulation


Secondary Outcome Measures :
  1. Difference of reactivity to thermal stimulation from anti-phase to in-phase stimulation [ Time Frame: up to 3 months after consent ]
    Threshold for responsiveness to thermal stimulation

  2. Difference of reactivity to thermal stimulation from sham to in-phase stimulation [ Time Frame: up to 3 months after consent ]
    Threshold for responsiveness to thermal stimulation

  3. Change in slow wave activity on the night of the intervention will be compared to that on the night prior to the study session. [ Time Frame: up to 3 months after consent ]
    Slow wave activity calculated during N3 sleep

  4. Localization of slow waves [ Time Frame: up to 3 months after consent ]
    Brain regions with localization of EEG slow waves during dexmedetomidine sedation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206059


Locations
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United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Ben J Palanca, MD PhD Washington University School of Medicine
More Information
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Publications:

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Responsible Party: Ben J.A. Palanca, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04206059    
Other Study ID Numbers: 201907086
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action