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Search / Trial NCT06824077

Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle

Launched by UNIVERSITY OF ALBERTA · Feb 10, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a medication called dexmedetomidine to see if it can help patients in the Intensive Care Unit (ICU) get better sleep. Sleep is really important for our overall health, especially when we're in the hospital, as it helps our immune system function and supports our brain. In the ICU, many patients have trouble sleeping due to noise and frequent checks by staff. This study aims to find out if giving dexmedetomidine at night can help patients sleep more peacefully and feel more awake and alert the next day.

To participate in the trial, individuals need to be at least 18 years old, currently in the ICU, and expected to stay there for at least 48 hours. Participants will be divided into two groups: one will receive dexmedetomidine for two nights, while the other will not. Sleep quality will be measured using a portable sleep device. The study will include about 50 people and is expected to take around two years to complete. It's important to note that some patients may not be eligible due to certain health conditions or medications. Overall, this study hopes to improve sleep for ICU patients, which could lead to better recovery outcomes.

Gender

ALL

Eligibility criteria

  • 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

About University Of Alberta

The University of Alberta, a leading research institution in Canada, is dedicated to advancing healthcare through innovative clinical trials. With a strong commitment to scientific excellence and community health, the university facilitates cutting-edge research across various medical disciplines. Its interdisciplinary approach fosters collaboration among researchers, clinicians, and students, ensuring that clinical trials are designed and conducted with the utmost rigor and ethical standards. By leveraging its extensive resources and expertise, the University of Alberta aims to translate research findings into meaningful advancements in patient care and public health.

Locations

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported