Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

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

• Sleep
• Sedation Complication

Interventions

RADIATION

MRI

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

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.

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

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

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

0 db with QST

sham stimulation (0 dB volume)

DRUG

Dexmedetomidine

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

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.

Sponsors & Collaborators

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Ben J Palanca, MD PhD · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-01-20

Primary Completion

2022-06-01

Completion

2023-07-01

FDA Device

Yes

Countries

• United States

Study Locations