Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function: NAP-WORK Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Evolution of reactive hyperemia index (RHI)
研究概览
简要总结
Night shift work is well known to cause health disruption in short and long term. It has been reported that among healthcare workers, nurses slept less than 6 h/24h. Consequences of such short sleep duration has been associated to long term issues such as endothelial dysfunction associated with cardiovascular diseases, arterial hypertension and type 2 diabetes. Countermeasures such as nap at work has potential effects on reducing the prevalence of cardiovascular diseases. However, to our knowledge, no studies have objectively investigated the effects of napping on endothelial function in a longitudinal design. Therefore, this study aims to investigate the effect of a 30 minutes on-duty nap during night work for 12 weeks on caregivers endothelial dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being a paramedical caregiverr (nurse or care assistant) at Saint-Etienne University Hospital
- •Be aAged between 18 and 65
- •Working at least 80% of a full-time equivalent post
- •Working 12-hour shifts (day/night) in continuous care services
- •Being affiliated or entitled under a social security scheme
- •Havinge received informed information about the study and have co-signed, with the investigator, a consent to participate in the study
排除标准
- •Have made a tTrans meridian journey in the last month prior to the study
- •Have a mMedically diagnosed sleep disorder such asof the hypersomnia or insomnia type
- •Have a diagnosed and treated mental pathology
- •Usually take a nap in the workplace in a quiet room
- •Be pregnant or breastfeeding
- •Have medically diagnosed neurovascular or neuromuscular pathologies
研究组 & 干预措施
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: ECG Holter (Device)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: On-duty Nap (Behavioral)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: EndoPAT (Device)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Popmeter® (Device)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Panasonic EW3109 (Device)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Fasting blood sample (Biological)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Pichot fatigue scale (Other)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: French version of the Recovery Needs Scale (BRD) (Other)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: The Short-Form 36 (SF-36) (Other)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Pittsburgh Sleep Quality Index (PSQI) (Other)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Epworth questionnaire (Other)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: The Karolinska Sleepiness Scale (Other)
Nap group
The experimental group will be allocated to do a 30-min on-duty nap during night work, in a dedicated room between 1 am and 4 am.
干预措施: Actimeter (Device)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Control condition (30-min rest) (Behavioral)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Panasonic EW3109 (Device)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: EndoPAT (Device)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Popmeter® (Device)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: ECG Holter (Device)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Fasting blood sample (Biological)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Pichot fatigue scale (Other)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: French version of the Recovery Needs Scale (BRD) (Other)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: The Short-Form 36 (SF-36) (Other)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Pittsburgh Sleep Quality Index (PSQI) (Other)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Epworth questionnaire (Other)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: The Karolinska Sleepiness Scale (Other)
Control group
The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
干预措施: Actimeter (Device)
结局指标
主要结局
Evolution of reactive hyperemia index (RHI)
时间窗: Change between week 1 and 12
RHI is measured through the EndoPAT device® initially and at 12 weeks, and corresponds to the vascular reactivity following a 5-min occlusion on an arm
次要结局
- Evolution of pro-inflammatory biomarkers(Change between week 1 and 12)
- Evolution of alertness at work assessed(Change between week 1 and 12)
- Evolution of sleep time(Change between week 1 and 12)
- Evolution of sleep duration(Change between week 1 and 12)
- Evolution of pulse wave velocity (PWV)(Change between week 1 and 12)
- Evolution of blood markers of endothelial function(Change between week 1 and 12)
- Evolution of subjective Fatigue(Change between week 1 and 12)
- Evolution of recovery Needs(Change between week 1 and 12)
- Evolution of subjective sleepiness(Change between week 1 and 12)
- Evolution of blood pressure(Change between week 1 and 12)
- Evolution of heart rate variability (HRV)(Change between week 1 and 12)
- Evolution of state of health(Change between week 1 and 12)
- Evolution of sleep quality(Change between week 1 and 12)