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

NCT ID: NCT05955729

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-19

Study Completion Date

2025-12-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volonteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

On-duty Nap

Intervention Type BEHAVIORAL

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.

EndoPAT

Intervention Type DEVICE

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.

Popmeter®

Intervention Type DEVICE

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.

Panasonic EW3109

Intervention Type DEVICE

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.

ECG Holter

Intervention Type DEVICE

The Holter takes an ECG during the subject's daily activities at home.

Fasting blood sample

Intervention Type BIOLOGICAL

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).

Pichot fatigue scale

Intervention Type OTHER

The Pichot fatigue scale is an 8-item questionnaire, with a score above 22 indicating excessive fatigue.

French version of the Recovery Needs Scale (BRD)

Intervention Type OTHER

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 Short-Form 36 (SF-36)

Intervention Type OTHER

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).

Pittsburgh Sleep Quality Index (PSQI)

Intervention Type OTHER

24-question sleep quality assessment scale, a score \> 5 indicates poor sleep quality

Epworth questionnaire

Intervention Type OTHER

8-question sleepiness assessment scale, a score above 10 indicates excessive sleepiness

The Karolinska Sleepiness Scale

Intervention Type OTHER

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.

Actimeter

Intervention Type DEVICE

An actimeter will be worn on the non-dominant wrist, uninterrupted day and night, for 7 consecutive days.

Control group

The control group will be allocated to rest in a dedicated room without napping between 1 am and 4 am.

Group Type ACTIVE_COMPARATOR

Control condition (30-min rest)

Intervention Type BEHAVIORAL

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.

EndoPAT

Intervention Type DEVICE

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.

Popmeter®

Intervention Type DEVICE

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.

Panasonic EW3109

Intervention Type DEVICE

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.

ECG Holter

Intervention Type DEVICE

The Holter takes an ECG during the subject's daily activities at home.

Fasting blood sample

Intervention Type BIOLOGICAL

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).

Pichot fatigue scale

Intervention Type OTHER

The Pichot fatigue scale is an 8-item questionnaire, with a score above 22 indicating excessive fatigue.

French version of the Recovery Needs Scale (BRD)

Intervention Type OTHER

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 Short-Form 36 (SF-36)

Intervention Type OTHER

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).

Pittsburgh Sleep Quality Index (PSQI)

Intervention Type OTHER

24-question sleep quality assessment scale, a score \> 5 indicates poor sleep quality

Epworth questionnaire

Intervention Type OTHER

8-question sleepiness assessment scale, a score above 10 indicates excessive sleepiness

The Karolinska Sleepiness Scale

Intervention Type OTHER

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.

Actimeter

Intervention Type DEVICE

An actimeter will be worn on the non-dominant wrist, uninterrupted day and night, for 7 consecutive days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

On-duty Nap

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.

Intervention Type BEHAVIORAL

Control 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.

Intervention Type BEHAVIORAL

EndoPAT

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.

Intervention Type DEVICE

Popmeter®

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.

Intervention Type DEVICE

Panasonic EW3109

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.

Intervention Type DEVICE

ECG Holter

The Holter takes an ECG during the subject's daily activities at home.

Intervention Type DEVICE

Fasting blood sample

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).

Intervention Type BIOLOGICAL

Pichot fatigue scale

The Pichot fatigue scale is an 8-item questionnaire, with a score above 22 indicating excessive fatigue.

Intervention Type OTHER

French 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.

Intervention Type OTHER

The 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).

Intervention Type OTHER

Pittsburgh Sleep Quality Index (PSQI)

24-question sleep quality assessment scale, a score \> 5 indicates poor sleep quality

Intervention Type OTHER

Epworth questionnaire

8-question sleepiness assessment scale, a score above 10 indicates excessive sleepiness

Intervention Type OTHER

The Karolinska Sleepiness Scale

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.

Intervention Type OTHER

Actimeter

An actimeter will be worn on the non-dominant wrist, uninterrupted day and night, for 7 consecutive days.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

automatic blood pressure device portable electrocardiogram

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Frédéric ROCHE, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Saint Etienne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chu de Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-A01109-36

Identifier Type: OTHER

Identifier Source: secondary_id

23CH138

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.