WEsleep Trial: Improving Sleep in Hospitalized Patients
Netherlands396 participantsStarted 2023-04-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Subjective Sleep Quality during admission
Timeframe: Second night of admission (for medical patients), first postoperative night on ward (for surgical patients)
Trial details
NCT IDNCT05683483
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)