SleepEarly Phase 1DELDEXNCT06824077
Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle
A Early Phase 1 study testing Dexmedetomidine in people with Sleep and Delirium, run by University of Alberta.
Trial summary
Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Delirium, ICU Hospitalization
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Mar 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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*
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomised, Placebo Controlled Clinical Trial of Dexmedetomidine as Part of a Sleep Promotion Bundle to Improve Sleep in Intensive Care
Patients frequently experience problems with sleep while admitted to the ICU. Good sleep is important in ensuring that your immune system responds properly to infection, for your heart to function optimally, and to support normal brain function such as memory.
To address sleep problems in the ICU, a bundle of interventions to support more normal sleep are provided. These bundles consist of medications such as sedatives and environmental changes such as less frequent times being assessed overnight and noise reduction strategies. Although medications can make patients appear to be sleeping, most medications do not provide patients with restful sleep. More research is needed on medications that better mimick restful sleep. One such medication is dexmedetomidine. When formally measured dexmedetomidine can make sleep appear more like a patient sleeping at home as compared to the hospital.
Read more
The purpose of this study is to test whether giving a patient in the intensive care unit dexmedetomidine helps have a more restful sleep and possibly be more alert and/or interactive the next day.
To see if dexmedetomidine improves sleep, the investigators will compare the quality of sleep of two different groups of participants: one group that receives dexmedetomidine at night for 2 nights in a row and another group that does not. How well one sleeps will be measured, in either group, will be assessed by a portable sleep machine that is attached by several stickers.
This study is called a pilot or feasibility study. A pilot study assesses how easy it is to recruit patients, whether the sleep machine is tolerated, and amount of time sleep is measured.
It is anticipated that about 50 people will take part in this study. This study should take approximately 2 years to complete, and the results should be known in about 1-2 years thereafter.
- Conditions
- Sleep, Delirium, ICU Hospitalization, Critical Illness
- Being tested
- Dexmedetomidine, Control (placebo) group
- Keywords
- delirium, dexmedetomidine, sleep, intensive care unit, polysomnography
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (Optiflow) and intubated patients with delirium as part of routine care. The ICU bedside nurse will be responsible for using the lowest effective dose to achieve a Richmond Agitation Sedation Scale (RASS) of -2, up to a maximum of 1.2 mcg/kg/hr, while monitoring for adverse events such as bradycardia and hypotension.
Control (placebo) groupOther
The control group will receive an infusion of 0.9% saline at 5-45 ml/hr titrated to the lowest effective dose to achieve a RASS of -2 for two nights following randomization.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Dexmedetomidine will be prepared at a concentration of 4 mcg/ml by diluting 200 mcg/2 ml vials with 48 mL of 0.9% normal saline to a total volume of 50 ml. A maintenance infusion of 0.2-1.2 mcg/kg/hr will be initiated to sustain the sedative effect and promote sleep throughout the trial period. ICU nurses are experienced in titrating dexmedetomidine for both patients on high flow oxygen (optiflow) and intubated patients with delirium as part of routine care. Receives: Drug: Dexmedetomidine |
| Control | Placebo comparator | Patients randomized to the control group will receive a placebo daily for 2 consecutive nights. Receives: Other: Control (placebo) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
The number of participants enrolled per month will be reported with 95% confidence intervals. A recruitment rate of at least one participant per month per participating site will be considered supportive of progression to a larger trial.
Measured: 2 years
Secondary outcomes (2)
Protocol Adherence
Adherence to treatment duration protocol: The investigators will consider the main trial to be feasible if intervention is delivered 90% of scheduled duration (proportion of total hours study drug received during intervention period (20:00 - 06:00). Further, tolerance of Prodigy Sleep Machine will be evaluated for a similar proportion of time successfully worn (recordings that are of sufficient quality to permit analyses between 20:00 - 06:00). The investigators will report proportion of adherence with 95% confidence intervals.
Measured: 2 years
Sleep Quality Assessment
We will monitor overnight sleep using the NOXA1s Sleep System. A trained assessor will attach the device at 17:00, remove the device at 08:00 the following morning and reattach at 17:00 later the same day. The patients will undergo the sleep study for one night prior to randomization, if the quality of data is deemed acceptable then they will be randomized to one of the two experimental groups (dexmedetomidine or placebo) and undergo the sleep study for two additional nights for a maximum of three consecutive nights. The sleep assessment will be performed with the associated Noxturnal Sleep Study software.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Dec 2026 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06824077
- Sponsor's protocol ID
- Pro00147451
- Acronym
- DELDEX
- Status last verified
- Oct 2026
- First submitted
- 21 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: al investigator and Steering Committee approval, ethics approval or exemption where applicable, and a signed institutional data-sharing agreement prohibiting re-identification and unauthorized onward sharing. Data will be provided securely, consistent with participant consent, ethics approvals and institutional requirements.