WEsleep Trial: Improving Sleep in Hospitalized Patients

NCT05683483 | Completed

• 1 other identifier: WEsleep Trial
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Sleep Disturbance; Sleep Hygiene; Circadian Dysrhythmia; Surgery; Sleep Disorders, Circadian Rhythm

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  Second night of admission vs. a work- and workfree day 30 days before admission

• Diurnal phase shift of sleep-wake timing

  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 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 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

Study Arms (4)

Surgical WEsleep

EXPERIMENTAL

Patients admitted into the 3 surgical departments/clusters where the WEsleep interventions are implemented.

Other: WEsleep Interventions

Medical WEsleep

EXPERIMENTAL

Patients admitted into the 3 non-surgical departments/clusters where the WEsleep interventions are implemented

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

Interventions

WEsleep Interventions OTHER

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.

Medical WEsleep; Surgical WEsleep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam University Medical Centers

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Parasomnias; Sleep Hygiene; Sleep Disorders, Circadian Rhythm

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Health Behavior; Behavior; Chronobiology Disorders; Dyssomnias; Occupational Diseases

Study Officials

• Jeroen j.hermanides@amsterdamumc.nl, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

• Dirk Jan Stenvers, PhD

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As interventions will be implemented on the level of the department (for 6 departments), it will not be possible to blind health care providers, researchers or patients for the intervention that the patient is receiving.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endocrinologist, Principal Investigator

Model Details: 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..

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 13, 2023
• Study Start: April 11, 2023
• Primary Completion: March 1, 2024
• Study Completion: August 31, 2024
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)