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ICU sleep breakthrough? new drug trial aims for restful nights

NCT ID NCT06824077

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 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.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

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 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * 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

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  1. The official record

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  2. A doctor treating you

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More trials for these conditions

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