NCT07326579

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

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

December 24, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2030

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

December 24, 2025

Last Update Submit

March 11, 2026

Conditions

Keywords

Sleep educational programAlternating 12-hourday and night shift

Outcome Measures

Primary Outcomes (1)

  • Effect of a 6-month sleep education program

    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 Outcomes (4)

  • Assess the impact of the sleep education program on sleep quality

    6 months

  • Assess the impact of the sleep education program on participant state of health

    6 months

  • Assess the impact of the sleep education program on quality of life

    6 months

  • Assess the impact of the sleep education program on accidentology

    6 months

Study Arms (2)

Sleep educational

EXPERIMENTAL

Personalized educational program

Behavioral: Sleep educational

Control

NO INTERVENTION

Standard workplace medicine advice

Interventions

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.

Sleep educational

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chu Grenoble

Grenoble, 38000, France

Location

Hospices Civils de Lyon

Lyon, 69000, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

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

December 24, 2025

First Posted

January 8, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2030

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations