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Sleep study for ICU sedation halted after just 3 volunteers

NCT ID NCT01342328

Knowledge-focused Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to see if a sedative called dexmedetomidine produces sleep more like natural sleep than another sedative, propofol. Researchers planned to measure brain activity in 3 healthy volunteers during drug-induced and natural sleep. The trial was terminated early, so only limited data is available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dexmedetomidine (Precedex) and propofol
What this could lead to
If successful, this could help doctors choose sedatives that better mimic natural sleep for ICU patients, potentially reducing delirium.
What could go wrong
This was a very small, early-phase study in healthy volunteers, not patients. It was terminated early, so results are limited and may not apply to real ICU settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

3 people

The number who actually took part.

Started

May 2012

Finished

Nov 2012

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Volunteer agreement and written informed consent * Healthy female or male between 18 and 45 years of age * Body Mass Index \< 30 kg/m2 * Non-pregnant and non-lactating * Normal airway anatomy (Mallampati class I) Exclusion Criteria: * Subject has a history of recent alcohol or drug abuse * Subject is unable to communicate in English * Subject is unwilling to meet fast guidelines (fast light meal or non-human milk for at least 8 hours, and clear liquids at least for 2 hours prior to induction of sedation on the day of the study) * Subject has taken caffeine containing beverages less than 8 hours before study begins * Subject is not able to avoid sleep for a minimum of 16 hours prior to testing * Subject has a known allergy to either of the sedative-hypnotic drugs to be used in the study * Subject has abnormal airway anatomy, including loose teeth * Subject has any family history of complications from anesthesia * Subject has history of sleep apnea * Subject has any reported illness, upper respiratory tract infection, abnormal vital signs, or concerning findings on the physical exam for the past 6 weeks * Subject has a positive urine pregnancy test * Subject is unable to sleep supine.

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Conditions

The condition(s) this trial relates to.

Sleep Hygiene sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sleep disorders

Contacts and locations

Locations

  • University of California San Francisco

    San Francisco, California, 94143, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.