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

Study acronym: DELDEX
StatusNot Yet Recruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Mar 1, 2027 → Mar 1, 2028
See other at-risk trials from University of Alberta

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Mar 1, 2027 to Mar 1, 2028
    • Start date pushed from Oct 1, 2026 to Dec 1, 2026
    • Secondary endpoints: 1 to 2
    • Collaborators expanded, about 3 words
  2. Notable Start date: Aug 1, 2026 to Oct 1, 2026
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 1 of 1 entry
  3. Notable Start date: Feb 15, 2026 to Aug 1, 2026v6
  4. Notable Start date: Nov 15, 2025 to Feb 15, 2026v5
  5. Notable Start date: Aug 1, 2025 to Nov 15, 2025v4
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  1. Notable Start date: May 1, 2025 to Aug 1, 2025v3
  2. Notable Start date: Mar 1, 2025 to May 1, 2025v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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. 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.
Trial Details
NCT Number NCT06824077
Lead Sponsor University of Alberta
Collaborators: University Hospital Foundation
Conditions
(from sponsor)
Sleep, Delirium, ICU Hospitalization, Critical Illness
Related terms Critical Illness, Delirium
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov