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ACTIVE NOT RECRUITING
NCT04206059
NA

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2021-01-20

Completion Date

2023-07-01

Last Updated

2022-12-02

Healthy Volunteers

Yes

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 (65db) 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.

Locations (1)

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States