An interventional study of Multimodal Sleep Promotion Intervention in Sleep Wake Disorders and Critical Illness, sponsored by Fundación de investigación HM. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Fundación de investigación HM · Not applicable, Interventional, and Supportive care
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.
Sleep disruption is highly prevalent among critically ill patients admitted to intensive care units (ICUs). Previous studies have demonstrated that ICU patients frequently experience fragmented sleep, reduced deep sleep, and disruption of circadian rhythms. Poor sleep quality in the ICU has been associated with adverse outcomes, including delirium, impaired recovery, reduced patient satisfaction, and decreased overall well-being.
Multiple factors contribute to sleep disturbances in the ICU, including environmental noise, continuous light exposure, frequent nighttime nursing interventions, pain, discomfort associated with medical devices, and psychological distress. Although several non-pharmacological interventions have been evaluated individually, such as earplugs, eye masks, environmental modifications, and relaxation strategies, evidence regarding comprehensive multimodal approaches remains limited.
The purpose of this study is to evaluate the effectiveness of a multimodal sleep promotion intervention in adult postoperative ICU patients. The intervention combines individualized sleep hygiene education, use of earplugs and eye masks, environmental measures aimed at reducing noise and light exposure, and optimization of nursing care to minimize unnecessary nighttime interruptions.
This study is designed as a two-center, non-randomized controlled pilot study conducted in two adult ICUs within the same healthcare organization. One ICU will implement the multimodal sleep promotion intervention, while the second ICU will provide usual care. The study will assess patient-reported sleep quality and patient experience measures, as well as explore the influence of selected demographic and clinical characteristics on study outcomes.
The results of this pilot study will provide preliminary evidence regarding the feasibility and effectiveness of a multimodal sleep promotion strategy and will inform the design of future larger-scale controlled studies in critically ill populations.
747 studies on the registry are indexed under Sleep Wake Disorders; 182 are open to participants now.
This study's planned enrollment of 50 is below the median of 66 across 531 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Fundación de investigación HM is the lead sponsor of 22 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Participants admitted to the intervention ICU will receive a multimodal sleep promotion program consisting of individualized sleep hygiene education, provision of earplugs and eye masks, environmental measures to reduce nighttime noise and light exposure, and optimization of nursing care activities to minimize unnecessary sleep interruptions during the ICU stay.
Behavioral: Multimodal Sleep Promotion Intervention
Participants admitted to the control ICU will receive usual intensive care unit care without implementation of the structured multimodal sleep promotion program. Any sleep-related measures provided as part of routine clinical practice will be documented.
The multimodal sleep promotion intervention consists of four components: (1) individualized sleep hygiene education, including information on sleep physiology, the importance of minimizing nighttime disturbances, and strategies to improve sleep during ICU stay; (2) provision and encouragement of nighttime use of earplugs and an eye mask; (3) environmental modifications aimed at reducing noise, light exposure, and thermal discomfort during the night; and (4) optimization of nursing care activities by clustering non-urgent procedures and minimizing avoidable nighttime interruptions. The intervention is delivered throughout the ICU stay according to a structured sleep promotion protocol.
Sleep Quality Measured by the Richards-Campbell Sleep Questionnaire (RCSQ)
Sleep quality will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a validated patient-reported measure specifically developed for critically ill patients. The questionnaire consists of five visual analog scale items ranging from 0 to 100, with higher scores indicating better perceived sleep quality. The primary outcome will be the mean RCSQ score.
Time frame: Daily from Day 1 through ICU discharge, up to 7 days
Patient Experience Measured by the PPE-33 Questionnaire
Patient experience will be assessed using the validated Spanish version of the Picker Patient Experience Questionnaire (PPE-33). Higher scores indicate a more positive patient experience during hospitalization.
Time frame: At ICU discharge, up to 7 days after ICU admission
Perceived Sleep-Disrupting Factors
Patient-reported impact of environmental and clinical factors on sleep, including noise, light, nursing interventions, pain, anxiety, lack of privacy, temperature, and discomfort, measured using visual analogue scales ranging from 0 to 100.
Time frame: Daily from Day 1 through ICU discharge, up to 7 days
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2026; primary completion for Dec 2026, 3 months later.
Of 208 non-industry interventional studies with no phase under Sleep Wake Disorders, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 40. This study's planned 3 months is below that.
Counting every sponsor, half of 243 studies reached it within 19 months; a quarter within 6 and three quarters within 37.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Fundación de investigación HM