SleepWEsleepNCT05683483
WEsleep Trial: Improving Sleep in Hospitalized Patients
A study testing WEsleep Interventions in people with Sleep and Sleep Disturbance, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
In the WEsleep study, the investigators will perform a cluster randomized controlled trial. 3 surgical and 3 medical departments will be randomized to implement low-cost and simple interventions aimed at improving sleep in admitted patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep, Sleep Disturbance, Sleep Hygiene
- What is being tested?
- WEsleep Interventions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Apr 2023to 31 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Surgical patients:
- Adult (18+) patients
- Undergoing elective non-cardiac surgery with planned (post-operative) overnight stay
- Willing and able to provide informed consent
- Able to read and write in Dutch
- Medical patients:
Show all 9Show fewer
- Adult (18+) patients medical admission with expected stay of at least two nights
- Willing and able to provide informed consent
- Able to read and write in Dutch
Who cannot join
- Surgical patients: ASA score of 4 or higher
- Surgical patients: PACU admission during first postoperative night
- Admission on ICU-ward at any time during admission (both planned and unplanned, for both surgical and medical patients)
- Non-Dutch speaking
- Strict isolation (MRSA or aerogenic isolation)
- Pre-existing delirium or cognitive impairment
- NB: After starting inclusions, some patients were found to spend the first postoperative night on post-anesthesia care unit (PACU) instead of a WEsleep intervention or control department and after deliberation this was added as a criterium for exclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: WEsleep Trial: Improving Sleep With Non-pharmalogical Interventions in Hospitalized Patients
In the WEsleep study, the investigators will perform a cluster randomized controlled trial. 3 surgical and 3 medical departments will be randomized to implement low-cost and simple interventions aimed at improving sleep in admitted patients. Another 3 surgical and 3 medical departments will be randomized to function as control groups. Subjective sleep quality and sleep-wake timing will be assessed in adult medical and surgical patients admitted into one of 12 participating wards, using questionnaires and a sleep diary. In addition, in a subset of participants, objective sleep measures will be assessed in with an EEG headband and a sleep mat.
Read the detailed description
Objectives
Primary objective
Our primary objective is to investigate whether a set of low-cost and easily applicable interventions improves subjective sleep quality of hospitalized patients on the second night of admission (for medical patients) and first postoperative night (for surgical patients) as measured the Richards-Campbell sleep questionnaire, comparing between intervention and control departments.
Secondary objectives
- To investigate whether the WEsleep interventions improves subjective sleep quality for all night of admission (max. 7)
- To investigate whether the WEsleep interventions reduced the lowering of subjective sleep quality during admission when compared to subjective sleep quality before admission (on a work-free day 30 days before admission, retrospectively assessed at inclusion)
- To investigate whether the disruption of the circadian timing system (as measured by the diurnal phase shift of midpoint of sleep) was smaller for patients in the intervention group on the first postoperative night for surgical patients and the second night of admission for medical patients
- To investigate whether the WEsleep interventions reduced night-to-night changes in subjective sleep-wake timing (i.e. midpoint of sleep, on- and offset, duration, latency, inertia and daytime napping) for all nights of admission (max. 7)
- To investigate the association between the timing of food intake (i.e. first and last meal of the day and whether food was eaten after 21:00h) and sleep quality and timing.
- To investigate the association between quality of recovery and sleep quality and sleep-wake timing
- To investigate 30-day mortality for patients admitted into intervention and control departments
- To investigate 30-day incidence of delirium for patients admitted into intervention and control departments
- For surgical patients: to investigate the 30-day incidence of surgical site infections
- Objective sleep substudy: to investigate the difference between intervention and control departments in objective sleep efficiency of hospitalized patients on the second night of admission (in medical patients) and the first postoperative night on ward (in surgical patients) as measured by the Dreem-3 EEG-headband
- Objective sleep substudy: to investigate whether the WEsleep interventions reduced night-to-night changes in objective sleep-wake timing (i.e. midpoint of sleep, on- and offset, duration, latency, inertia and daytime napping) for all nights of admission (max. 7)
- Objective sleep substudy: to investigate whether the WEsleep interventions influence night-to-night changes in objective sleep measures (as measured by the Dreem 3 EEG-headband and Withings Sleep analyzer) for all nights of admission (max. 7)
- Objective sleep substudy: to investigate the difference between objective sleep measures (as measured by Dreem-3 EEG-headband and Withings Sleep Analyzer) and subjective sleep measures (as measured by the Richard Campbell Sleep Questionnaire and the Consensus Sleep Diary) for a population of hospitalized medical and surgical patients
- Objective sleep substudy: to investigate the association between quality of recovery and objective sleep quality and sleep-wake timing
- Objective sleep substudy: to investigate the association between 30-day mortality and objective sleep quality and quantity
- Objective sleep substudy: to investigate the association between 30-day incidence of delirium and objective sleep quality and quantity
- Objective sleep substudy: to investigate the association between the 30-day incidence of surgical site infections and objective sleep quality and quantity (for surgical patients)
Study Procedure:
6 departments will be randomized (3 surgical, 3 medical) to receive the WEsleep-interventions, which will consist of: 1) Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity.
Implementation of the interventions will be evaluated on a regular basis throughout the length of the study to make sure that all interventions are provided to our patients as planned.
Before implementation, a baseline measurement will be conducted on all participating departments in a small number of patients (which is not part of the sample size). After study onset, we observed that some interventions were gradually implemented. As such, we decided that for optimal assessment of the effect of the intervention a run-in period of 12 weeks before starting assessment of the primary and secondary outcomes would be reasonable. Sleep measurements between study onset and outcome will be used to guide implementation and will be reported in eventual journal articles. After 12 weeks (that is, after July 1st), 33 patients per participating department will be included, for a total of 396 patients (12 departments with 33 patients each) and analyzed for the outcomes of the study. Informed consent for sleep measurements will be obtained on the first or second day of admission into one of the participating wards. Patients will be followed until discharge or for a maximum of 7 nights of admission. Patient characteristics, as well as data on the admission will be extracted from the electronic medical record.
In the objective sleep substudy, 24 patients will be recruited from each group (medical intervention and control groups, surgical intervention and control groups), for a total of 96 patients. Measurements between April 11th and June 30th will be used to guide implementation of interventionsPatients included after July 1st will be analyzed for the outcomes of the substudy. Informed consent for the substudy will be obtained separately at the same time as consent for the main study. All patients participating in the main study will be asked to participate in the substudy as well. After obtaining consent, a lottery system will decide which patients can participate in the substudy (due to the scarcity of available Dreem-3 EEG headbands and Withings Sleep Analyzers). Patients will be asked to complete two questionnaires daily:
Richards Campbell Sleep Questionnaire (RCSQ) on subjective sleep quality Consensus Sleep Diary (CSD) for day-to-day sleep wake timing during admission Furthermore, patients are asked at admission to complete the two questionnaires on sleep quality and sleep-wake timing on work- and work-free days (RCSQ and CSD) retrospectively, i.e. for 30 days before admission. Patients will also complete a Quality of Recovery 15 (QoR-15) questionnaire twice (once at one day after surgery/first day of admission and once three days after surgery/third day of admission).
In the substudy, objective sleep in patients will be measured with the Dreem-3 EEG-headband and the Withings Sleep Analyzer. The Dreem-3 headband uses electro-encephalography (EEG) and a validated algorithm to differentiate between wakefulness and various sleep stages (Rapid-Eye Movement (REM)-sleep and non-REM N1, N2 and N3 sleep) and the time at which these occur. The Withings Sleep Analyzer can be placed under the mattress and uses measurement of movement to differentiate between wakefulness and light, deep and REM-sleep and the times at which these occur.
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene, Circadian Dysrhythmia, Surgery, Sleep Disorders, Circadian Rhythm
- Being tested
- WEsleep Interventions
- Medical subject headings
- Parasomnias, Sleep Hygiene, Sleep Disorders, Circadian Rhythm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEsleep InterventionsOther
- Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity.
| Study group | Role | What they receive |
|---|---|---|
| Surgical WEsleep | Experimental | Patients admitted into the 3 surgical departments/clusters where the WEsleep interventions are implemented. Receives: Other: WEsleep Interventions |
| Medical WEsleep | Experimental | Patients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are implemented Receives: Other: WEsleep Interventions |
| Surgical Standardcare | No intervention | Patients admitted into the 3 surgical departments/clusters where the WEsleep interventions are NOT implemented, and patients are receiving standardcare |
| Medical Standardcare | No intervention | Patients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are NOT implemented, and patients are receiving standardcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Sleep Quality during admission
Subjective sleep quality will be assessed with the Richard Campbell Sleep Questionnaire (RCSQ). The RCSQ measures sleep quality on five questions using a visual analogue scale (VAS), ranging from 0 to 100, with higher scores indicating a better sleep quality.
A sixth question was added to assess noise levels (as is quite customary), using a VAS-scale, ranging from 0-100, with a higher score indicating more noise
Measured: Second night of admission (for medical patients), first postoperative night on ward (for surgical patients)
Secondary outcomes (17)
Night-to night changes in subjective sleep quality
Subjective sleep quality will be assessed with the Richard Campbell Sleep Questionnaire (RCSQ). The RCSQ measures sleep quality on five questions using a visual analogue scale (VAS), ranging from 0 to 100, with higher scores indicating a better sleep quality.
A sixth question was added to assess noise levels (as is quite customary), using a VAS-scale, ranging from 0-100, with a higher score indicating more noise
Measured: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Difference in subjective sleep quality between during admission and at home
Subjective sleep quality will be assessed with the Richard Campbell Sleep Questionnaire, with five questions on a visual analogue scale, ranging from 0 to 100, with higher scores indicating better sleep quality. For this outcome, we will assess the subjective sleep quality at home retrospectively at inclusion.
Measured: Second night of admission vs. a work- and workfree day 30 days before admission
Diurnal phase shift of sleep-wake timing
The phase shift of sleep-wake timing will be assessed by comparing midpoint of sleep during admission with midpoint of sleep on a work-free day before admission, both measured with the Consensus Sleep Diary (CSD). For this outcome, we will assess sleep-wake timing at home retrospectively at inclusion.
Measured: Second night of admission (for medical patients) or first postoperative night (for surgical patients) vs. a workfree day 30 days before admission
Night-to-night changes in sleep-wake timing
The changes in sleep-wake timing (i.e. midpoint of sleep, sleep on- and offset time, sleep duration, sleep latency \& inertia and daytime napping), as measured by the CSD.
Measured: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Timing of food intake and sleep quality/timing
The association between food intake timing (i.e. first and last meal of the day and whether food was eaten after 21:00h), as measured by asking patients directly for the time of the first and last meal of the day and whether patients ate after 21:00h), and subjective sleep quality and sleep-wake timing (as measured by the Richard Campbell Sleep Questionnaire (with five questions on a visual analogue scale ranging from 0-100 with higher scores indicating better sleep quality) and Consensus Sleep Diary (with questions on sleep-wake timing) respectively).
Measured: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Quality of recovery (for surgical patients) and sleep quality/timing
The association between quality of recovery (in surgical patients), as measured by the Quality-of-Recovery 15 item questionnaire (QoR-15), and subjective sleep quality and sleep-wake timing (as measured by the Richard Campbell Sleep Questionnaire and Consensus Sleep Diary respectively). The QoR-15 will be completed twice by patients.
Measured: First and third day after surgery
30 day mortality
30-day mortality, assessed by checking the medical record retrospectively 30 days after admission.
Measured: 30 days after admission
30-day incidence of delirium during admission
30-day incidence of the clinical diagnosis of delirium during hospitalization, as assessed by a physician during admission. Patients will be assessed for delirium at the request of nursing staff or if the score of the Delirium Observation Screening scale is 3 or higher. The Delirium Observation Screening scale ranges from 0 to 39, with higher scores indicating a higher chance of delirium.
Measured: 30 days after admission
30-day incidence of surgical site infections (for surgical patients)
30-day incidence of surgical site infections, as assessed by physicians from the department where patient is admitted during hospitalization. If the patient obtained a surgical site infection after discharge, incidence was assessed in the outpatient clinic by a physician from the department where patient was admitted.
Measured: 30 days after admission
Objective sleep substudy: Sleep efficiency (objectively measured) during admission
Objective sleep quality will be measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep. The primary outcome measure will be sleep efficiency (time slept divided by time in bed spent trying to sleep), compared for patients on intervention and control departments.
Measured: Second night of admission (medical patients) and first postoperative night on surgical ward (for surgical patients)
Objective sleep substudy: Differences in objective sleep measures of sleep-wake timing during admission
Sleep-wake timing will be assessed by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the Withings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep. Changes in sleep-wake timing (i.e. midpoint of sleep, sleep on- and offset time, sleep duration, sleep latency \& inertia) will be compared for patients on intervention and control departments.
Measured: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Objective sleep substudy: Night-to-night changes in objective sleep measures during admission
Objective sleep quality will be measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the WIthings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep. The amount of time in each of these stages and their distribution, as well as total sleep time, will be compared for patients on intervention and control departments.
Measured: The first night until the seventh night of admission; if the patient is discharged before seven nights of admission, all nights of admission will be analyzed
Objective sleep substudy: Difference between objective and subjective sleep measures during admission
Objective sleep quality will be measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the WIthings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep. Subjective sleep quality will be measured by the Richard Campbell Sleep Questionnaire, with five questions with a visual analogue scale with scores from 0 to 100, with higher scores indicating better sleep quality. Subjective sleep quantity will be measured with the Consensus Sleep Diary, with questions on sleep-wake timing. Objective and subjective sleep measures will be compared.
Measured: The first night until the seventh night of admission; if the patient is discharged before seven nights of admission, all nights of admission will be analyzed)
Objective sleep substudy: Quality of recovery after surgery and objective sleep quality/timing
The association between quality of recovery, as measured by the Quality-of-Recovery 15 item questionnaire (QoR-15), and objective sleep quality and sleep-wake timing (as measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the Withings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep.). The QoR-15 will be completed twice by patients.
Measured: First and third day after surgery (surgical patients)
Objective sleep substudy: Correlation 30 day mortality and objective sleep quality/timing
Correlation between 30-day mortality, assessed by checking the medical record retrospectively 30 days after admission and objective sleep quality and sleep-wake timing during admission (as measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the Withings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep.
Measured: 30 days after admission
Objective sleep substudy: Correlation 30-day incidence of delirium during admission and objective sleep quality/timing
30-day incidence of the clinical diagnosis of delirium during hospitalization, as assessed by a physician during admission. Patients will be assessed for delirium at the request of nursing staff or if the score of the Delirium Observation Screening scale is 3 or higher. The Delirium Observation Screening scale ranges from 0 to 39, with higher scores indicating a higher chance of delirium. Objective sleep quality and sleep-wake timing during admission will be measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the Withings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep.).
Measured: 30 days after admission
Objective sleep substudy: Correlation 30-day incidence of surgical site infections (for surgical patients) and objective sleep quality/timing
30-day incidence of surgical site infections, as assessed by physicians from the department where patient is admitted during hospitalization. If the patient obtained a surgical site infection after discharge, incidence was assessed in the outpatient clinic by a physician from the department where patient was admitted. Objective sleep quality and sleep-wake timing during admission will be measured by the Dreem-3 headband, using electro-encephalography (EEG) to differentiate between wakefulness, Rapid-Eye-Movement (REM) sleep and non-REM N1, N2 and N3 sleep, and the Withings Sleep Analyzer, differentiating between wakefulness, REM- and light and deep sleep.).
Measured: 30 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start11 Apr 2023
- Primary completion1 Mar 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will perform a cluster randomized controlled trial. Randomization will be stratified, to ensure that departments are comparable at baseline in terms of types of patients, and that not all intervention departments are in one of our two locations and all control departments in the other location..
- Masking
- None (open label)
- Enrolment
- 396 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Jan Stenvers, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Jeroen j.hermanides@amsterdamumc.nl, PhD, Principal investigator, Amsterdam UMCDirk Jan Stenvers, PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05683483
- Sponsor's protocol ID
- WEsleep Trial
- Acronym
- WEsleep
- Status last verified
- Jul 2025
- First submitted
- 23 Dec 2022
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Gans CJ, van den Ende ES, Meewisse AJG, van Zuylen ML, Stenvers DJ, Hermanides J, Nanayakkara PWB. Benzodiazepine receptor agonists in hospitalised patients in the Netherlands: initiation, continuation and discontinuation - a retrospective observational analysis. BMJ Open. 2026 Feb 9;16(2):e112758. doi: 10.1136/bmjopen-2025-112758.
PubMed 41663167
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEsleep Trial: Improving Sleep With Non-pharmalogical Interventions in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT05683483
- Acronym / sponsor ID
- WEsleep / WEsleep Trial
- Conditions
- Sleep, Sleep Disturbance, Sleep Hygiene, Circadian Dysrhythmia, Surgery, Sleep Disorders, Circadian Rhythm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 396 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 13 Jan 2023 (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.
In the WEsleep study, the investigators will perform a cluster randomized controlled trial. 3 surgical and 3 medical departments will be randomized to implement low-cost and simple interventions aimed at improving sleep in admitted patients. Another 3 surgical and 3 medical departments will be randomized to function as control groups. Subjective sleep quality and sleep-wake timing will be assessed in adult medical and surgical patients admitted into one of 12 participating wards, using questionnaires and a sleep diary. In addition, in a subset of participants, objective sleep measures will be assessed in with an EEG headband and a sleep mat.
Detailed description
Objectives
Primary objective
Our primary objective is to investigate whether a set of low-cost and easily applicable interventions improves subjective sleep quality of hospitalized patients on the second night of admission (for medical patients) and first postoperative night (for surgical patients) as measured the Richards-Campbell sleep questionnaire, comparing between intervention and control departments.
Secondary objectives
- To investigate whether the WEsleep interventions improves subjective sleep quality for all night of admission (max. 7)
- To investigate whether the WEsleep interventions reduced the lowering of subjective sleep quality during admission when compared to subjective sleep quality before admission (on a work-free day 30 days before admission, retrospectively assessed at inclusion)
- To investigate whether the disruption of the circadian timing system (as measured by the diurnal phase shift of midpoint of sleep) was smaller for patients in the intervention group on the first postoperative night for surgical patients and the second night of admission for medical patients
- To investigate whether the WEsleep interventions reduced night-to-night changes in subjective sleep-wake timing (i.e. midpoint of sleep, on- and offset, duration, latency, inertia and daytime napping) for all nights of admission (max. 7)
- To investigate the association between the timing of food intake (i.e. first and last meal of the day and whether food was eaten after 21:00h) and sleep quality and timing.
- To investigate the association between quality of recovery and sleep quality and sleep-wake timing
- To investigate 30-day mortality for patients admitted into intervention and control departments
- To investigate 30-day incidence of delirium for patients admitted into intervention and control departments
- For surgical patients: to investigate the 30-day incidence of surgical site infections
- Objective sleep substudy: to investigate the difference between intervention and control departments in objective sleep efficiency of hospitalized patients on the second night of admission (in medical patients) and the first postoperative night on ward (in surgical patients) as measured by the Dreem-3 EEG-headband
- Objective sleep substudy: to investigate whether the WEsleep interventions reduced night-to-night changes in objective sleep-wake timing (i.e. midpoint of sleep, on- and offset, duration, latency, inertia and daytime napping) for all nights of admission (max. 7)
- Objective sleep substudy: to investigate whether the WEsleep interventions influence night-to-night changes in objective sleep measures (as measured by the Dreem 3 EEG-headband and Withings Sleep analyzer) for all nights of admission (max. 7)
- Objective sleep substudy: to investigate the difference between objective sleep measures (as measured by Dreem-3 EEG-headband and Withings Sleep Analyzer) and subjective sleep measures (as measured by the Richard Campbell Sleep Questionnaire and the Consensus Sleep Diary) for a population of hospitalized medical and surgical patients
- Objective sleep substudy: to investigate the association between quality of recovery and objective sleep quality and sleep-wake timing
- Objective sleep substudy: to investigate the association between 30-day mortality and objective sleep quality and quantity
- Objective sleep substudy: to investigate the association between 30-day incidence of delirium and objective sleep quality and quantity
- Objective sleep substudy: to investigate the association between the 30-day incidence of surgical site infections and objective sleep quality and quantity (for surgical patients)
Study Procedure:
6 departments will be randomized (3 surgical, 3 medical) to receive the WEsleep-interventions, which will consist of: 1) Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity.
Implementation of the interventions will be evaluated on a regular basis throughout the length of the study to make sure that all interventions are provided to our patients as planned.
Before implementation, a baseline measurement will be conducted on all participating departments in a small number of patients (which is not part of the sample size). After study onset, we observed that some interventions were gradually implemented. As such, we decided that for optimal assessment of the effect of the intervention a run-in period of 12 weeks before starting assessment of the primary and secondary outcomes would be reasonable. Sleep measurements between study onset and outcome will be used to guide implementation and will be reported in eventual journal articles. After 12 weeks (that is, after July 1st), 33 patients per participating department will be included, for a total of 396 patients (12 departments with 33 patients each) and analyzed for the outcomes of the study. Informed consent for sleep measurements will be obtained on the first or second day of admission into one of the participating wards. Patients will be followed until discharge or for a maximum of 7 nights of admission. Patient characteristics, as well as data on the admission will be extracted from the electronic medical record.
In the objective sleep substudy, 24 patients will be recruited from each group (medical intervention and control groups, surgical intervention and control groups), for a total of 96 patients. Measurements between April 11th and June 30th will be used to guide implementation of interventionsPatients included after July 1st will be analyzed for the outcomes of the substudy. Informed consent for the substudy will be obtained separately at the same time as consent for the main study. All patients participating in the main study will be asked to participate in the substudy as well. After obtaining consent, a lottery system will decide which patients can participate in the substudy (due to the scarcity of available Dreem-3 EEG headbands and Withings Sleep Analyzers). Patients will be asked to complete two questionnaires daily:
Richards Campbell Sleep Questionnaire (RCSQ) on subjective sleep quality Consensus Sleep Diary (CSD) for day-to-day sleep wake timing during admission Furthermore, patients are asked at admission to complete the two questionnaires on sleep quality and sleep-wake timing on work- and work-free days (RCSQ and CSD) retrospectively, i.e. for 30 days before admission. Patients will also complete a Quality of Recovery 15 (QoR-15) questionnaire twice (once at one day after surgery/first day of admission and once three days after surgery/third day of admission).
In the substudy, objective sleep in patients will be measured with the Dreem-3 EEG-headband and the Withings Sleep Analyzer. The Dreem-3 headband uses electro-encephalography (EEG) and a validated algorithm to differentiate between wakefulness and various sleep stages (Rapid-Eye Movement (REM)-sleep and non-REM N1, N2 and N3 sleep) and the time at which these occur. The Withings Sleep Analyzer can be placed under the mattress and uses measurement of movement to differentiate between wakefulness and light, deep and REM-sleep and the times at which these occur.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- We will perform a cluster randomized controlled trial. Randomization will be stratified, to ensure that departments are comparable at baseline in terms of types of patients, and that not all intervention departments are in one of our two locations and all control departments in the other location..
| Arm | Type | Receives |
|---|---|---|
| Surgical WEsleep | Experimental | Other: WEsleep InterventionsPatients admitted into the 3 surgical departments/clusters where the WEsleep interventions are implemented. |
| Medical WEsleep | Experimental | Other: WEsleep InterventionsPatients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are implemented |
| Surgical Standardcare | No intervention | –Patients admitted into the 3 surgical departments/clusters where the WEsleep interventions are NOT implemented, and patients are receiving standardcare |
| Medical Standardcare | No intervention | –Patients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are NOT implemented, and patients are receiving standardcare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult (18+) patients
- Undergoing elective non-cardiac surgery with planned (post-operative) overnight stay
- Willing and able to provide informed consent
- Able to read and write in Dutch
- Adult (18+) patients medical admission with expected stay of at least two nights
Key exclusion criteria (7 listed)
- Surgical patients: ASA score of 4 or higher
- Surgical patients: PACU admission during first postoperative night
- Admission on ICU-ward at any time during admission (both planned and unplanned, for both surgical and medical patients)
- Non-Dutch speaking
- Strict isolation (MRSA or aerogenic isolation)
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 |
|---|---|---|
| WEsleep Interventions1) Postponing morning nursing rounds to avoid waking patients early and daily assessment of sleep quality by the nurse during morning rounds; 2) Implementing sleep promoting interventions, including optimization of medication and iv fluid timing; 3) Education for health care professionals on sleep; 4) Implementing sleep rounds and change department infrastructure; including 'sleep menu' where patients can choose from earplugs, eye masks, and warm socks. Implement blackout curtains depending on baseline light intensity. | Other | Medical WEsleep, Surgical WEsleep |
Primary outcome
Subjective Sleep Quality during admission
Time frame: Second night of admission (for medical patients), first postoperative night on ward (for surgical patients)
Subjective sleep quality will be assessed with the Richard Campbell Sleep Questionnaire (RCSQ). The RCSQ measures sleep quality on five questions using a visual analogue scale (VAS), ranging from 0 to 100, with higher scores indicating a better sleep quality. A sixth question was added to assess noise levels (as is quite customary), using a VAS-scale, ranging from 0-100, with a higher score indicating more noise
17 secondary outcomes
Night-to night changes in subjective sleep quality
Time frame: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Difference in subjective sleep quality between during admission and at home
Time frame: Second night of admission vs. a work- and workfree day 30 days before admission
Diurnal phase shift of sleep-wake timing
Time frame: Second night of admission (for medical patients) or first postoperative night (for surgical patients) vs. a workfree day 30 days before admission
Night-to-night changes in sleep-wake timing
Time frame: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Timing of food intake and sleep quality/timing
Time frame: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Quality of recovery (for surgical patients) and sleep quality/timing
Time frame: First and third day after surgery
30 day mortality
Time frame: 30 days after admission
30-day incidence of delirium during admission
Time frame: 30 days after admission
30-day incidence of surgical site infections (for surgical patients)
Time frame: 30 days after admission
Objective sleep substudy: Sleep efficiency (objectively measured) during admission
Time frame: Second night of admission (medical patients) and first postoperative night on surgical ward (for surgical patients)
Objective sleep substudy: Differences in objective sleep measures of sleep-wake timing during admission
Time frame: The first night until the seventh night of admission; if the patient is discharged before 7 nights of admission, all nights of admission will be analyzed
Objective sleep substudy: Night-to-night changes in objective sleep measures during admission
Time frame: The first night until the seventh night of admission; if the patient is discharged before seven nights of admission, all nights of admission will be analyzed
Objective sleep substudy: Difference between objective and subjective sleep measures during admission
Time frame: The first night until the seventh night of admission; if the patient is discharged before seven nights of admission, all nights of admission will be analyzed)
Objective sleep substudy: Quality of recovery after surgery and objective sleep quality/timing
Time frame: First and third day after surgery (surgical patients)
Objective sleep substudy: Correlation 30 day mortality and objective sleep quality/timing
Time frame: 30 days after admission
Objective sleep substudy: Correlation 30-day incidence of delirium during admission and objective sleep quality/timing
Time frame: 30 days after admission
Objective sleep substudy: Correlation 30-day incidence of surgical site infections (for surgical patients) and objective sleep quality/timing
Time frame: 30 days after admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Derived from this study: PubMed 41663167de Gans CJ, van den Ende ES, Meewisse AJG, van Zuylen ML, Stenvers DJ, Hermanides J, Nanayakkara PWB. Benzodiazepine receptor agonists in hospitalised patients in the Netherlands: initiation, continuation and discontinuation - a retrospective observational analysis. BMJ Open. 2026 Feb 9;16(2):e112758. doi: 10.1136/bmjopen-2025-112758.
- 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. This study is not recruiting at the moment.
Jeroen j.hermanides@amsterdamumc.nl, PhD principal investigator
Amsterdam UMC
Dirk Jan Stenvers, PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WEsleep Interventions in people with Sleep and Sleep Disturbance, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 9 inclusion and 7 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: finished, as of the sponsor's last update on 10 Jul 2025. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Sleep Quality during admission (time frame: Second night of admission (for medical patients), first postoperative night on ward (for surgical patients)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05683483, which also lists 1 linked publication.
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 10 Jul 2025.