ICU sleep breakthrough? new drug trial aims for restful nights
NCT ID NCT06824077
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a medication called dexmedetomidine can help patients in the intensive care unit (ICU) sleep more restfully. Good sleep is important for recovery, but ICU conditions often disrupt it. About 50 adult ICU patients will either receive the medication or a placebo for two nights, and their sleep quality will be measured with a portable sleep monitor. The goal is to see if this approach improves sleep and helps patients feel more alert the next day.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adult patient aged 18 years old or over admitted to the ICU * Anticipated to stay in the ICU for another 48 hours after the first sleep recording * Mechanically ventilated or on high flow oxygen (Optiflow) * Hemodynamically stable * Conscious, non-sedated patient with capacity to complete a self-reported sleep assessment\* Exclusion Criteria: * Contraindication to dexmedetomidine (including but not limited to allergy and bradycardia \[heart rate \< 50 beats per minute\]) * Currently receiving dexmedetomidine or other alpha-2 agonists (e.g., clonidine) * Patients with structural neurological disease (e.g., stroke or tumor or traumatic brain injury) or degenerative neurologic disease (e.g., Parkinson's disease or dementia) and GCS \< 14 * Patients with second- or third-degree heart block (unless pacemaker implanted) * Patients with clinically significant hepatic or renal disease * Patients with limitations in therapy or actively being palliated * Patients with primary psychiatric disorder (e.g., new diagnosis of or uncontrolled schizophrenia, severe depression) * Patients experiencing substance intoxication or withdrawal (e.g., severely agitated delirium) * Patients participating in other studies involving the use of pharmacologically active substances * Treating clinician believes study participation is not in the patient's best interest * Pregnancy or breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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