Clinical Trial

Multimodal Sleep Promotion in Surgical ICU Patients

Study acronym: MULTISLEEP
Not Yet Recruiting
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Summary
Sleep disturbances are highly prevalent among patients admitted to intensive care units (ICUs). Critical illness, environmental factors, and routine clinical care frequently result in fragmented sleep, reduced sleep quality, and disruption of normal circadian rhythms. Previous studies have shown that poor sleep in ICU patients may be associated with delirium, impaired recovery, decreased functional outcomes, and lower patient satisfaction. Environmental factors such as noise generated by alarms and medical equipment, continuous light exposure, frequent nursing interventions, pain, anxiety, and discomfort related to invasive devices have been identified as major contributors to sleep disruption in critically ill patients. Several non-pharmacological interventions, including earplugs, eye masks, environmental modifications, and nursing care bundles, have demonstrated potential benefits in improving sleep quality. However, most studies have focused on isolated interventions, and evidence regarding comprehensive multimodal approaches remains limited. This two-center non-randomized controlled pilot study aims to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and reorganization of nursing care activities to minimize unnecessary sleep interruptions. Patients admitted to the intervention ICU will receive the multimodal sleep promotion program, while patients admitted to the control ICU will receive usual care. The primary objective is to assess the effect of the intervention on patient-reported sleep quality. Secondary objectives include evaluating patient experience during ICU stay and exploring the relationship between sleep outcomes and selected demographic and clinical variables. The findings of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of multimodal sleep promotion strategies in adult ICU settings and may support the development of future larger-scale studies.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-10-30 -> 2026-12-30 2026-07-17
minor Completion pushed: 2026-11-30 -> 2027-01-30 2026-07-17
Trial Details
NCT Number NCT07672509
Lead Sponsor Fundación de investigación HM
Conditions Sleep Wake Disorders, Critical Illness
Enrollment 50 participants
Start Date 2026-09-01
Primary Completion 2026-12-30 (estimated)
Study Completion 2027-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-16