Effects of a Sleep Education Program on the Health Status of Healthcare Workers Working 12-hour Alternating Day-night Shifts (SLEEPMORE)

March 11, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

Effects of a Sleep Education Program Conducted by Occupational Health Nurse on the Health Status of Healthcare Workers Working 12-hour Alternating Day-night Shifts: a Multicentre Randomised Controlled Trial

In a context of seeking a better balance between personal and professional life and labor shortages, the use of 12-hour alternating day-night shifts has become more common in work organizations, particularly in healthcare facilities. This work pattern combines exposure to alternating day and night shifts with long working hours, raising questions about its effects on health, particularly sleep quality and cardiovascular risk. Staff working alternating day/night or night shifts are at risk of cardiovascular disease, particularly in connection with sleep deprivation and the adoption of individual behaviors that increase the risk (smoking, poor diet, alcohol consumption, smoking and low physical activity). However sleep education is not integrated in a personalized way into the prevention advice provided by occupational health services.

Therefore, this study aims to investigate the effects of a 6-month sleep education program conducted by occupational health nursing staff, on the sleep duration of healthcare workers newly exposed to alternating 12-hour day and night shifts.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38000
        • CHU Grenoble
        • Contact:
        • Principal Investigator:
          • Claire VETTIER, MD
      • Lyon, France, 69000
        • Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Laure PETER DEREX, PhD
      • Saint-Etienne, France, 42055

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Being a paramedical caregiverr (nurse or care assistant)
  • Working 12-hour shifts (day/night)
  • Working at least 80% of a full-time equivalent post
  • Staff employed at a hospital listed among the investigating centers
  • Being affiliated or entitled under a social security scheme
  • Having received informed information about the study and have co- signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

  • Nursing staff and nursing assistants who have been exposed for more than six months to alternating 12-hour shifts or atypical working hours (two eight-hour shifts, three eight-hour shifts or night shifts) during their professional career
  • Nursing staff and nursing assistants with a history of mental illness or who are taking medication that affects alertness (psychotropic drugs)
  • Pregnant or breastfeeding women
  • Nursing staff or nursing assistants with sleep apnea syndrome, central hypersomnolence disorders, severe parasomnias, severe untreated restless legs syndrome
  • Individuals with children under the age of 1 in the household
  • Trans meridian travel (>2 time zones) during the month prior to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sleep educational
Personalized educational program
Behavioral: Sleep educational

Participants will undergo :

  • standardized monitoring initially (M0), then at 6 months (M6) and 12 months (M12)
  • a personalized educational program, including an initial consultation with a sleep doctor and a nurse, followed by monthly follow-ups with an occupational health nurse.
No Intervention: Control
Standard workplace medicine advice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of a 6-month sleep education program
Time Frame: 6 months
Evaluate the effect of a 6-month sleep education program conducted by occupational health nursing staff on the sleep duration of nursing assistants newly exposed to alternating 12-hour day and night shifts.Absolute difference in average sleep duration (in minutes) measured over 14 days from an actigraph worn at the wrist, between Baseline (M0) and at 6 months (M6).
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess the impact of the sleep education program on sleep quality
Time Frame: 6 months
The Pittsburgh Sleep Quality Index (PSQI) comprises 24 items, with scores ranging from 0 to 21, where a score > 5 indicates poor sleep quality)
6 months
Assess the impact of the sleep education program on participant state of health
Time Frame: 6 months
Measure of cardiac frequency
6 months
Assess the impact of the sleep education program on quality of life
Time Frame: 6 months
The Short Form 36 (SF-36) will be used to assess quality of life. This 36-item questionnaire includes 8 sub-scores ranging from 0 (minimum quality of life) to 100 (maximum well-being).
6 months
Assess the impact of the sleep education program on accidentology
Time Frame: 6 months
Number of commuting accidents, workplace accidents, road accidents, near misses related to drowsiness
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

December 24, 2025

First Submitted That Met QC Criteria

December 24, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 11, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25PH236
  • 2025-A02584-45 (Other Identifier: N°ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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