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 range

18 Years – 40 Years

Sex

ALL

See this in plain English?

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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