WEsleep Trial: Improving Sleep in Hospitalized Patients — WEsleep  

Surgery Clinical Trial

Official title: WEsleep Trial: Improving Sleep With Non-pharmalogical Interventions in Hospitalized Patients

Status Recruiting

Clinical 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. 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Circadian Dysrhythmia
• Dyssomnias
• Parasomnias
• Sleep
• Sleep Disorders, Circadian Rhythm
• Sleep Disturbance
• Sleep Hygiene
• Sleep Wake Disorders
• Surgery

• NCT number: NCT05683483
• Study type: Interventional
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Jeroen Hermanides, PhD
• Phone: +31 20 566 9111
• Email: j.hermanides@amsterdamumc.nl
• Status: Recruiting
• Phase: N/A
• Start date: April 11, 2023
• Completion date: April 1, 2024