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CompletedNCT05955729

Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function

Effect of a Short Nap During the Night Shift of Healthcare Workers on Endothelial Function: NAP-WORK Randomized Controlled Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
80 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALOn-duty NapFor 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.
BEHAVIORALControl condition (30-min rest)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.
DEVICEEndoPATThe 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.
DEVICEPopmeter®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.
DEVICEPanasonic EW3109Diastolic 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.
DEVICEECG HolterThe Holter takes an ECG during the subject's daily activities at home.
BIOLOGICALFasting blood sample15 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).
OTHERPichot fatigue scaleThe Pichot fatigue scale is an 8-item questionnaire, with a score above 22 indicating excessive fatigue.
OTHERFrench version of the Recovery Needs Scale (BRD)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.
OTHERThe Short-Form 36 (SF-36)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).
OTHERPittsburgh Sleep Quality Index (PSQI)24-question sleep quality assessment scale, a score \> 5 indicates poor sleep quality
OTHEREpworth questionnaire8-question sleepiness assessment scale, a score above 10 indicates excessive sleepiness
OTHERThe Karolinska Sleepiness ScaleThe Karolinska Sleepiness Scale measures daytime sleepiness on a 9-point scale, based on 5 states and 4 intermediate states that are not verbally indicated.
DEVICEActimeterAn actimeter will be worn on the non-dominant wrist, uninterrupted day and night, for 7 consecutive days.

Timeline

Start date
2024-02-19
Primary completion
2025-09-26
Completion
2025-12-22
First posted
2023-07-21
Last updated
2026-01-13

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT05955729. Inclusion in this directory is not an endorsement.