Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

N/ACompletedNCT04206059

Washington University School of Medicine18 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Sleep Sedation Complication

Interventions

MRIRADIATION

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

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.

Home sleep studyDIAGNOSTIC_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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Sham stimulation and in-phase stimulation blocks during the intervention

Secondary Outcomes

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

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.

Data from ClinicalTrials.gov

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