An interventional study of Triple Sleep-Promotion Protocol in Delirium Confusional State, sponsored by Naile ALANKAYA. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Naile ALANKAYA · Not applicable, Interventional, and Prevention
Delirium is a common complication in intensive care units (ICUs) and may be associated with sleep disruption and frequent nighttime disturbances. This randomized controlled trial will evaluate whether a multicomponent nighttime sleep-promotion intervention, called the Triple Sleep-Promotion Protocol, can reduce the occurrence of new-onset delirium in adult ICU patients.
The study is being conducted in four ICUs in Türkiye. Eligible patients who do not have delirium at the beginning of the study will be randomly assigned to either the intervention group or the control group. The intervention includes clustering nighttime nursing care, offering an eye mask and earplugs during protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible. Patients in the control group will receive usual ICU care. Patient safety and clinically necessary care will take priority over all sleep-promotion procedures.
Participants will be followed during their ICU stay for up to five days. Delirium will be assessed twice daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Nighttime sleep quality will also be assessed each morning using the Richards-Campbell Sleep Questionnaire. The primary aim is to determine whether the Triple Sleep-Promotion Protocol reduces the incidence of new-onset delirium compared with usual ICU care.
Sleep disruption is common among critically ill patients and may contribute to the development of delirium. Nighttime sleep in the ICU can be disrupted by environmental light and noise, frequent nursing activities, monitoring, and other clinically necessary procedures. Non-pharmacological strategies that reduce avoidable nighttime disturbances may therefore represent a feasible approach to supporting sleep and preventing delirium without adding medication-related risks.
The Triple Sleep-Promotion Protocol was developed as a multicomponent nursing intervention integrating clustered nighttime nursing care, protected sleep periods, eye mask and earplug use, and pragmatic reduction of avoidable nighttime light and noise. The protocol is designed to reduce modifiable sleep disturbances while maintaining routine clinical monitoring and prioritizing patient safety and necessary care at all times.
This multicenter randomized controlled trial will examine whether implementation of the Triple Sleep-Promotion Protocol reduces new-onset delirium compared with usual ICU care. The study will also evaluate subjective nighttime sleep quality and document intervention adherence and clinically necessary protocol interruptions.
88 studies on the registry are indexed under Confusion; 19 are open to participants now.
This study's planned enrollment of 200 is above the median of 115 across 56 interventional studies indexed under Confusion.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm receive usual ICU care according to the routine practices of the participating ICU. No study-specific nighttime care clustering, eye mask, earplugs, or structured reduction of nighttime light and noise is provided as part of the study. All routine clinical monitoring, nursing care, and medically necessary procedures continue according to standard ICU practice.
Participants assigned to this arm receive the Triple Sleep-Promotion Protocol in addition to usual ICU care. The protocol includes clustering nighttime nursing care, offering an eye mask and earplugs during designated protected sleep periods, and reducing avoidable nighttime light and noise whenever clinically feasible. The intervention is implemented during the nighttime period, approximately 22:00-08:00. Urgent or clinically necessary care, monitoring, and patient safety requirements take priority over all sleep-promotion procedures.
Other: Triple Sleep-Promotion Protocol
The Triple Sleep-Promotion Protocol is a multicomponent, non-pharmacological nighttime nursing intervention implemented approximately between 22:00 and 08:00. Nursing care is clustered within three designated periods (22:00-01:00, 02:30-04:00, and 05:30-07:00) to support two protected sleep periods (01:00-02:30 and 04:00-05:30). During the protected sleep periods, participants are offered an eye mask and earplugs, and avoidable environmental light and noise are reduced whenever clinically feasible. Urgent or clinically necessary nursing care, medical procedures, monitoring, and patient safety requirements take priority over the protocol. If the evening RASS score is -4 or -5, the sleep-promotion intervention is withheld for that night and the participant is reassessed subsequently. The intervention is discontinued after the first positive CAM-ICU assessment.
Incidence of New-Onset Delirium
New-onset delirium is defined as at least one positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment during ICU follow-up. Only participants who are CAM-ICU negative at baseline are randomized. Richmond Agitation-Sedation Scale (RASS) is assessed before each CAM-ICU assessment; CAM-ICU is performed when RASS is -3 or higher, while RASS -4 or -5 is recorded as not assessable.
Time frame: Up to 5 days after randomization
Subjective Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire
Subjective sleep quality is assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), a five-item instrument evaluating the preceding night's sleep. Each item is scored from 0 to 100, and the mean of the five items is calculated as the overall RCSQ score (range: 0-100). Higher scores indicate better perceived sleep quality. The RCSQ is administered each morning between 07:00 and 08:00 during ICU follow-up. Assessments are discontinued after the first positive CAM-ICU assessment.
Time frame: Daily during ICU follow-up, up to 5 days after randomization
Plan to share: No
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