Effects of a multicomponent sleep enhancement protocol on delirium incidence in elderly critically ill surgical patients: a randomized controlled trial

Abstract

Background: Sleep disturbances are common in critically ill patients and increase delirium risk, leading to worse outcomes. Non-pharmacologic sleep interventions show mixed results, with limited randomized controlled trial (RCT) data in surgical ICU populations. Methods: We conducted a prospective, single-blind randomized controlled trial in a surgical ICU to evaluate a multicomponent sleep enhancement protocol vs. usual care in patients aged ≥ 65 years with expected ICU stays > 24 h. The intervention included environmental modifications (noise and light reduction, closed doors, alarm adjustments) and patient-specific measures (earplugs, eye masks). Delirium incidence over 7 days was assessed using the Thai version of CAM–ICU by blinded evaluators. Sleep quality was measured daily with the Richards–Campbell Sleep Questionnaire (RCSQ). Bayesian methods estimated treatment effects and posterior probabilities of benefit. Results: Of 177 patients analyzed (89 intervention, 88 control), delirium occurred in 10.1% of the intervention group vs. 17.0% in controls (Bayesian OR 0.55; 95% credible interval [CrI] 0.22–1.31; posterior probability of benefit 90.6%). In a predefined high-risk subgroup, delirium incidence was 14.0% vs. 30.0% (OR 0.38; 95% CrI 0.12–1.83; posterior probability of benefit 95.7%). Sleep quality scores and clinical outcomes did not differ significantly. Adherence was high for environmental modifications but moderate for earplugs and eye masks. Conclusions: Among elderly surgical ICU patients, a multicomponent, non-pharmacologic sleep enhancement protocol was associated with a high posterior probability of reducing delirium during the early ICU period, despite no measurable improvement in subjective sleep quality. The findings are hypothesis-generating; given the protocol’s simplicity and low risk, confirmation in larger multicenter trials with objective sleep measures and strategies to optimize adherence is warranted. Trial registration: This study was registered with the Thai Clinical Trials Registry (TCTR: https://www.thaiclinicaltrials.org) under the registration number TCTR20221129003, with the registration date of 29 November 2022. TCTR20221129003