CompletedNot Applicable

Closed Loop Acoustic Stimulation During Sedation With Dexmedetomidine

United States18 participantsStarted 2021-01-20

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

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

Timeframe: Sham stimulation and in-phase stimulation blocks during the intervention

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

Timeframe: Anti-phase and in-phase blocks during the intervention

Difference in EEG Slow Wave Density From Anti-phase to In-phase Stimulation

Timeframe: anti-phase and in-phase blocks during the intervention

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

Timeframe: Sham stimulation and in-phase stimulation blocks during the intervention

Trial details

NCT IDNCT04206059

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-01

Results submitted2023-06-01

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