Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

NCT04206059 | Completed Results FDA Device

• 1 other identifier: 201907086
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation Complication; Sleep

Outcome Measures

Primary Outcomes (4)

• Difference in EEG Slow Wave Activity From Sham to In-phase Stimulation

  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

  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

  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

  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 Outcomes (3)

• Difference of Reactivity to Thermal Stimulation From Anti-phase to In-phase Stimulation

  Anti-phase and in-phase blocks of the intervention

• Difference of Reactivity to Thermal Stimulation From Sham to In-phase Stimulation

  Sham and in-phase blocks during intervention

• Slow Wave Activity Calculated During N3 Sleep

  on the nights before and the night of the intervention

Study Arms (3)

CLASS-D Cohort - In-phase

EXPERIMENTAL

Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated peak of EEG slow wave oscillation

Radiation: MRI; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: Acoustic stimulation (65 decibels or db) up-slope of EEG with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task

CLASS-D Cohort - Anti-phase

ACTIVE COMPARATOR

Within-subject crossover cohort with intervention, acoustic stimulation delivered in phase with the anticipated trough of EEG slow wave oscillation

Radiation: MRI; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: Acoustic stimulation (65db) down-slope of EEG with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task

CLASS-D Cohort - Sham

SHAM COMPARATOR

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; Diagnostic Test: Quantitative Sensory Testing (QST); Diagnostic Test: Home sleep study; Other: 0 db with QST; Drug: Dexmedetomidine; Other: Breathe-Squeeze Task

Interventions

MRI RADIATION

A non-contrast brain MRI will be acquired for localizing EEG slow waves

Also known as: Structural magnetic resonance imaging

CLASS-D Cohort - Anti-phase; CLASS-D Cohort - In-phase; CLASS-D Cohort - Sham

Quantitative Sensory Testing (QST) DIAGNOSTIC_TEST

Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.

Also known as: Quantitative Sensory Testing

CLASS-D Cohort - Anti-phase; CLASS-D Cohort - In-phase; CLASS-D Cohort - Sham

Home sleep study DIAGNOSTIC_TEST

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.

Also known as: Unattended polysomnography

CLASS-D Cohort - Anti-phase; CLASS-D Cohort - In-phase; CLASS-D Cohort - Sham

Acoustic stimulation (65db) down-slope of EEG with QST OTHER

65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)

Also known as: Anti-phase CLAS with sensory testing

CLASS-D Cohort - Anti-phase

0 db with QST OTHER

sham stimulation (0 dB volume)

Also known as: Sham CLAS with sensory testing

CLASS-D Cohort - Sham

Dexmedetomidine DRUG

All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml

Also known as: Dexmedetomidine hydrochloride

CLASS-D Cohort - Anti-phase; CLASS-D Cohort - In-phase; CLASS-D Cohort - Sham

Breathe-Squeeze Task OTHER

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.

Also known as: Internally directed behavioral task

CLASS-D Cohort - Anti-phase; CLASS-D Cohort - In-phase; CLASS-D Cohort - Sham

Acoustic stimulation (65 decibels or db) up-slope of EEG with QST OTHER

Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves

Also known as: In-phase CLAS with sensory testing

CLASS-D Cohort - In-phase

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

• Prerau MJ, Brown RE, Bianchi MT, Ellenbogen JM, Purdon PL. Sleep Neurophysiological Dynamics Through the Lens of Multitaper Spectral Analysis. Physiology (Bethesda). 2017 Jan;32(1):60-92. doi: 10.1152/physiol.00062.2015.

  PMID: 27927806 BACKGROUND

• Leger D, Debellemaniere E, Rabat A, Bayon V, Benchenane K, Chennaoui M. Slow-wave sleep: From the cell to the clinic. Sleep Med Rev. 2018 Oct;41:113-132. doi: 10.1016/j.smrv.2018.01.008. Epub 2018 Feb 5.

  PMID: 29490885 BACKGROUND

• Neske GT. The Slow Oscillation in Cortical and Thalamic Networks: Mechanisms and Functions. Front Neural Circuits. 2016 Jan 14;9:88. doi: 10.3389/fncir.2015.00088. eCollection 2015.

  PMID: 26834569 BACKGROUND

• Smith SK, Kafashan M, Rios RL, Brown EN, Landsness EC, Guay CS, Palanca BJA. Daytime dexmedetomidine sedation with closed-loop acoustic stimulation alters slow wave sleep homeostasis in healthy adults. BJA Open. 2024 Mar 28;10:100276. doi: 10.1016/j.bjao.2024.100276. eCollection 2024 Jun.

  PMID: 38571816 DERIVED

• Guay CS, Hight D, Gupta G, Kafashan M, Luong AH, Avidan MS, Brown EN, Palanca BJA. Breathe-squeeze: pharmacodynamics of a stimulus-free behavioural paradigm to track conscious states during sedation☆. Br J Anaesth. 2023 May;130(5):557-566. doi: 10.1016/j.bja.2023.01.021. Epub 2023 Mar 24.

  PMID: 36967282 DERIVED

MeSH Terms

Interventions

Acoustic Stimulation; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ben Palanca
• Organization: Washington University School of Medicine

palancab@wustl.edu

314-273-9076

Study Officials

• Ben J Palanca, MD PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 20, 2019
• Study Start: January 20, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2023
• Last Updated: May 1, 2026
• Results First Posted: May 1, 2026

Record last verified: 2026-04

Locations

US (1)