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NCT Number: NCT07326579

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

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.

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Key information

Conditions

Healthy Volunteers (HV)

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Grenoble, Grenoble, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep educational

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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)

  2. Assess the impact of the sleep education program on participant state of health

    Time frame: 6 months

    Measure of cardiac frequency

  3. 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).

  4. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: SLEEPMORE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jan 8, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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