Delirium Confusional StateNCT07801092
Triple Sleep-promotion Protocol for Delirium Prevention in Intensive Care Patients
A study testing Triple Sleep-Promotion Protocol in people with Delirium Confusional State, run by Naile ALANKAYA at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium Confusional State
- What is being tested?
- Triple Sleep-Promotion Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Admitted to one of the participating intensive care units.
- Expected ICU stay of at least 24 hours.
- Richmond Agitation-Sedation Scale (RASS) score between -3 and +4 at baseline.
- Negative Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment at baseline.
- Able to communicate in Turkish when communication is required for study assessments.
- Written informed consent provided by the patient or, when the patient is unable to provide consent because of their clinical condition, by a first-degree relative.
Who cannot join
- Positive CAM-ICU assessment at baseline.
- Dementia or a severe neurological disorder that may interfere with delirium assessment, including stroke or severe head trauma.
- Delirium related to alcohol or substance withdrawal.
- Visual or hearing impairment that prevents implementation of the sleep-promotion intervention.
- Ear infection or tympanic membrane perforation that precludes the use of earplugs.
- Terminal clinical condition.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sevda Ateş contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Çanakkale, Çanakkale, 17100
Ayten Dinç, PhD, aytendinc@comu.edu.tr
About this study
Official title: Effect of a Triple Sleep-promotion Protocol on Delirium Incidence in Intensive Care Units: A Multicenter Stratified Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Delirium Confusional State
- Being tested
- Triple Sleep-Promotion Protocol
- Keywords
- Intensive Care Unit, Sleep Promotion, Delirium Prevention, Nursing Intervention
- Medical subject headings
- Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple Sleep-Promotion ProtocolOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual ICU Care | No intervention | 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. |
| Triple Sleep-Promotion Protocol | Experimental | 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. Receives: Other: Triple Sleep-Promotion Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 5 days after randomization
Secondary outcomes (1)
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.
Measured: Daily during ICU follow-up, up to 5 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start15 Aug 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium Confusional StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are individually randomized in a 1:1 ratio to either the Triple Sleep-Promotion Protocol plus usual ICU care or usual ICU care alone. Randomization is stratified by study center using variable block sizes of 4 and 6.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Naile ALANKAYA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Naile ALANKAYA, Çanakkale Onsekiz Mart University
- Investigators
- Naile Alankaya, Principal investigator, Çanakkale Onsekiz Mart University, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801092
- Sponsor's protocol ID
- COMU-SBF-NA-05
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Triple Sleep-promotion Protocol on Delirium Incidence in Intensive Care Units: A Multicenter Stratified Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07801092
- Acronym / sponsor ID
- COMU-SBF-NA-05
- Conditions
- Delirium Confusional State
- Keywords
- Intensive Care Unit, Sleep Promotion, Delirium Prevention, Nursing Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Naile ALANKAYAUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are individually randomized in a 1:1 ratio to either the Triple Sleep-Promotion Protocol plus usual ICU care or usual ICU care alone. Randomization is stratified by study center using variable block sizes of 4 and 6.
| Arm | Type | Receives |
|---|---|---|
| Usual ICU Care | No intervention | –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. |
| Triple Sleep-Promotion Protocol | Experimental | Other: Triple Sleep-Promotion ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older.
- Admitted to one of the participating intensive care units.
- Expected ICU stay of at least 24 hours.
- Richmond Agitation-Sedation Scale (RASS) score between -3 and +4 at baseline.
- Negative Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) assessment at baseline.
Key exclusion criteria (6 listed)
- Positive CAM-ICU assessment at baseline.
- Dementia or a severe neurological disorder that may interfere with delirium assessment, including stroke or severe head trauma.
- Delirium related to alcohol or substance withdrawal.
- Visual or hearing impairment that prevents implementation of the sleep-promotion intervention.
- Ear infection or tympanic membrane perforation that precludes the use of earplugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triple Sleep-Promotion ProtocolThe 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. | Other | Triple Sleep-Promotion Protocol |
Primary outcome
Incidence of New-Onset Delirium
Time frame: Up to 5 days after randomization
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.
1 secondary outcome
Subjective Sleep Quality Assessed by the Richards-Campbell Sleep Questionnaire
Time frame: Daily during ICU follow-up, up to 5 days after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sevda Ateş contact
Naile Alankaya principal investigator
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple Sleep-Promotion Protocol in people with Delirium Confusional State, run by Naile ALANKAYA at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naile Alankaya, Assosiate Prof. PhD (+905334256510, naile.alankaya@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of New-Onset Delirium (time frame: Up to 5 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.