Clinical trial NCT05683483: WEsleep Trial: Improving Sleep in Hospitalized Patients
Official title: WEsleep Trial: Improving Sleep With Non-pharmalogical Interventions in Hospitalized Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sleep
Sleep Disturbance
Sleep Hygiene
Circadian Dysrhythmia
Surgery
Sleep Disorders, Circadian Rhythm
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 396
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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..
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Surgical: Patients admitted for elective surgery with planned overnight stay Medical:Patients admitted to the medical ward, with at least two expected nights of admission

Inclusion Criteria:

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:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Subjective Sleep Quality during admission
timeFrame: Second night of admission (for medical patients), first postoperative night on ward (for surgical patients)
Secondary outcomes:
measure: Night-to night changes in subjective sleep quality
timeFrame: 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
measure: Difference in subjective sleep quality between during admission and at home
timeFrame: Second night of admission vs. a work- and workfree day 30 days before admission
measure: Diurnal phase shift of sleep-wake timing
timeFrame: Second night of admission (for medical patients) or first postoperative night (for surgical patients) vs. a workfree day 30 days before admission
measure: Night-to-night changes in sleep-wake timing
timeFrame: 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
measure: Timing of food intake and sleep quality/timing
timeFrame: 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
measure: Quality of recovery (for surgical patients) and sleep quality/timing
timeFrame: First and third day after surgery
measure: 30 day mortality
timeFrame: 30 days after admission
measure: 30-day incidence of delirium during admission
timeFrame: 30 days after admission
measure: 30-day incidence of surgical site infections (for surgical patients)
timeFrame: 30 days after admission
measure: Objective sleep substudy: Sleep efficiency (objectively measured) during admission
timeFrame: Second night of admission (medical patients) and first postoperative night on surgical ward (for surgical patients)
measure: Objective sleep substudy: Differences in objective sleep measures of sleep-wake timing during admission
timeFrame: 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
measure: Objective sleep substudy: Night-to-night changes in objective sleep measures during admission
timeFrame: 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
measure: Objective sleep substudy: Difference between objective and subjective sleep measures during admission
timeFrame: 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)
measure: Objective sleep substudy: Quality of recovery after surgery and objective sleep quality/timing
timeFrame: First and third day after surgery (surgical patients)
measure: Objective sleep substudy: Correlation 30 day mortality and objective sleep quality/timing
timeFrame: 30 days after admission
measure: Objective sleep substudy: Correlation 30-day incidence of delirium during admission and objective sleep quality/timing
timeFrame: 30 days after admission
measure: Objective sleep substudy: Correlation 30-day incidence of surgical site infections (for surgical patients) and objective sleep quality/timing
timeFrame: 30 days after admission
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam University Medical Centers
Study officials:
affiliation: Amsterdam UMC
name: Jeroen j.hermanides@amsterdamumc.nl, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amsterdam UMC
name: Dirk Jan Stenvers, PhD
role: PRINCIPAL_INVESTIGATOR
References: