ICU SLEEP

**Background.** Sleep deprivation is common and severe among ICU patients and
is hypothesized to be a key modifiable risk factor for delirium.
Dexmedetomidine (Dex), an α2A agonist, has been shown in prior trials to
reduce ICU delirium, but the dosing strategy that best balances efficacy and
safety is not established.

**Trial.** ICU-SLEEP (ClinicalTrials.gov NCT03355053) was a single-center,
phase 2, double-blind, parallel-arm, placebo-controlled, three-arm randomized
superiority trial conducted at Massachusetts General Hospital between January
2019 and March 2022. Non-ventilated adults aged 50 and older expected to
remain in the ICU overnight were randomized 1:1:1 to one of three intravenous
overnight (20:00-07:00, up to 7 consecutive ICU nights) infusions: low-dose
dexmedetomidine (0.3 mcg/kg/h), very-low-dose dexmedetomidine (0.1 mcg/kg/h),
or normal-saline placebo. The primary endpoint was in-hospital delirium-free
days (IH-DFDs) over the first 14 hospital days; the secondary endpoint was ICU
delirium-free days (ICU-DFDs) over the first 7 ICU days.

**This release.** 482 patients were enrolled, 347 received the intervention,
and 312 entered the modified intention-to-treat analysis. This data and code
release accompanies the primary trial manuscript (currently in preparation for
peer-reviewed submission). It contains the de-identified per-patient dataset
together with the analysis pipeline used in the paper, so that the published
findings can be independently reproduced from the raw inputs. Please consult
the published paper for the full results and clinical interpretation.