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Completed

NCT Number: NCT04206059

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

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.

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Key information

Conditions

Sleep Sedation Complication

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

MRI

Radiation

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

Other names: Structural magnetic resonance imaging

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.

Other names: Quantitative Sensory Testing

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.

Other names: Unattended polysomnography

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

Other names: In-phase CLAS with sensory testing

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)

Other names: Anti-phase CLAS with sensory testing

0 db with QST

Other

sham stimulation (0 dB volume)

Other names: Sham CLAS with sensory testing

Dexmedetomidine

Drug

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

Other names: Dexmedetomidine hydrochloride

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.

Other names: Internally directed behavioral task

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Acronym: CLASS-D

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 20, 2019
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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