Clinical trial NCT05955729: Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function
Official title: Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function: NAP-WORK Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Volonteers
Keywords: Nap
Endothelial function
Shift work
Nurses
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evolution of reactive hyperemia index (RHI)
timeFrame: Change between week 1 and 12
Secondary outcomes:
measure: Evolution of pulse wave velocity (PWV)
timeFrame: Change between week 1 and 12
measure: Evolution of blood pressure
timeFrame: Change between week 1 and 12
measure: Evolution of heart rate variability (HRV)
timeFrame: Change between week 1 and 12
measure: Evolution of pro-inflammatory biomarkers
timeFrame: Change between week 1 and 12
measure: Evolution of blood markers of endothelial function
timeFrame: Change between week 1 and 12
measure: Evolution of subjective Fatigue
timeFrame: Change between week 1 and 12
measure: Evolution of recovery Needs
timeFrame: Change between week 1 and 12
measure: Evolution of state of health
timeFrame: Change between week 1 and 12
measure: Evolution of sleep quality
timeFrame: Change between week 1 and 12
measure: Evolution of subjective sleepiness
timeFrame: Change between week 1 and 12
measure: Evolution of alertness at work assessed
timeFrame: Change between week 1 and 12
measure: Evolution of sleep time
timeFrame: Change between week 1 and 12
measure: Evolution of sleep duration
timeFrame: Change between week 1 and 12
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu de Saint-Etienne
Study officials:
affiliation: Centre Hospitalier Universitaire de Saint Etienne
name: Frédéric ROCHE, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: