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Multimodal Sleep Promotion in Surgical ICU Patients

Study acronym: MULTISLEEP
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: Jul 1, 2026 to Sep 1, 2026
    • Primary completion pushed from Oct 30, 2026 to Dec 30, 2026
    • Study completion pushed from Nov 30, 2026 to Jan 30, 2027
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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.
Trial Details
NCT Number NCT07672509
Lead Sponsor Fundación de investigación HM
Conditions
(from sponsor)
Sleep Wake Disorders, Critical Illness
Related terms Critical Illness, Sleep Hygiene, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov