NCT05683483已完成不适用
WEsleep Trial: Improving Sleep With Non-pharmalogical Interventions in Hospitalized Patients
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 396 人开始时间: 2023年4月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 1
- 主要终点
- Subjective Sleep Quality during admission
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Subjective Sleep Quality during admission
时间窗: 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
次要结局
- 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)
- 30-day incidence of surgical site infections (for surgical patients)(30 days after admission)
- 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)
- Quality of recovery (for surgical patients) and sleep quality/timing(First and third day after surgery)
- 30 day mortality(30 days after admission)
- 30-day incidence of delirium during admission(30 days after admission)
- Objective sleep substudy: Sleep efficiency (objectively measured) during admission(Second night of admission (medical patients) and first postoperative night on surgical ward (for surgical patients))
- Objective sleep substudy: Quality of recovery after surgery and objective sleep quality/timing(First and third day after surgery (surgical patients))
- Objective sleep substudy: Correlation 30 day mortality and objective sleep quality/timing(30 days after admission)
- Objective sleep substudy: Correlation 30-day incidence of delirium during admission and objective sleep quality/timing(30 days after admission)
- 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)
- Objective sleep substudy: Differences in objective sleep measures of sleep-wake timing during admission(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(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(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: Correlation 30-day incidence of surgical site infections (for surgical patients) and objective sleep quality/timing(30 days after admission)
研究者
Dirk Jan Stenvers
Endocrinologist, Principal Investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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