Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function
NAP-WORK
2 other identifiers
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2023
CompletedFirst Posted
Study publicly available on registry
July 21, 2023
CompletedStudy Start
First participant enrolled
February 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 26, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2025
CompletedJanuary 13, 2026
January 1, 2026
1.6 years
June 23, 2023
January 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of reactive hyperemia index (RHI)
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
Change between week 1 and 12
Secondary Outcomes (13)
Evolution of pulse wave velocity (PWV)
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 pro-inflammatory biomarkers
Change between week 1 and 12
Evolution of blood markers of endothelial function
Change between week 1 and 12
- +8 more secondary outcomes
Study Arms (2)
Nap group
EXPERIMENTALThe 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.
Control group
ACTIVE COMPARATORThe control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.
Interventions
The tool is connected to the caregiver's finger and toe via photodiode sensors. Its simple operation enables reproducible measurement of the propagation speed of the pulse wave in 14 seconds.
Diastolic and systolic blood pressure measured 3 times in succession using an automatic blood pressure monitor (Panasonic EW3109) in the sitting position on the left arm.
The Holter takes an ECG during the subject's daily activities at home.
15 ml blood sample (venous sampling) will be taken to measure inflammatory biomarkers (hsCRP, IL-6 TNF-α, IL-1β) and blood markers of endothelial function (NO, CRP, SOD, IL-18).
The Pichot fatigue scale is an 8-item questionnaire, with a score above 22 indicating excessive fatigue.
BRD questionnaire consists of 11 items coded 0 or 1. A score is calculated for each participant, multiplied by 10 to give a score ranging from 0 to 100. The greater the need for recovery, the higher the score.
The SF-36 questionnaire is used to assess quality of life. It comprises 8 sub-scores ranging from 0 (minimum quality of life) to 100 (maximum well-being).
24-question sleep quality assessment scale, a score \> 5 indicates poor sleep quality
8-question sleepiness assessment scale, a score above 10 indicates excessive sleepiness
The Karolinska Sleepiness Scale measures daytime sleepiness on a 9-point scale, based on 5 states and 4 intermediate states that are not verbally indicated.
An actimeter will be worn on the non-dominant wrist, uninterrupted day and night, for 7 consecutive days.
For 12 weeks, an opportunity for a 30-minute nap during the night shift, between 1 a.m. and 4 a.m., in a quiet room with facilities for lying down.
For 12 weeks, an opportunity for a 30-minute rest during the night shift, between 1 a.m. and 4 a.m., in a quiet room without facilities for lying down or napping.
The EndoPAT device® measures vascular reactivity after a 5-minute occlusion on one arm. This device measures changes in vascular tone induced by the endothelium at fingertip level using a pair of plethysmographic sensors. The measurement consists of performing a reference recording for 5 minutes on the 2 arms, then a test arm is chosen to perform an occlusion for 5 minutes while continuing the recording.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu de Saint-Etienne
Saint-Etienne, 42055, France
Related Publications (1)
Bouchou Y, Monnier M, Roche F, Pelissier C, Berger M. Effect of 12 weeks with a 30-min nap opportunity during the night shift of healthcare workers on early cardiovascular risk biomarkers: the NAPWORK study protocol of a randomised controlled trial. BMJ Open. 2026 Jan 22;16(1):e110108. doi: 10.1136/bmjopen-2025-110108.
PMID: 41571410DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric ROCHE, MD PhD
Centre Hospitalier Universitaire de Saint Etienne
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2023
First Posted
July 21, 2023
Study Start
February 19, 2024
Primary Completion
September 26, 2025
Study Completion
December 22, 2025
Last Updated
January 13, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share