Healthy Volunteers (HV)SLEEPMORENCT07326579
Effects of a Sleep Education Program on the Health Status of Healthcare Workers Working 12-hour Alternating Day-night Shifts
A study testing Sleep educational in people with Healthy Volunteers (HV), run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers (HV)
- What is being tested?
- Sleep educational
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2026to 1 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Chu Grenoble
Grenoble, 38000
Claire VETTIER, MD, 04 76 76 51 23 ext. 33, cvettier@chu-grenoble.fr
Claire VETTIER, MD
Hospices Civils de Lyon
Lyon, 69000
Laure PETER DEREX, PhD, 04-72-07-17-69 ext. 33, laure.peter-derex@chu-lyon.fr
Laure PETER DEREX, PhD
Chu Saint-Etienne
Saint-Etienne, 42055
Carole PELISSIER, PhD, 04 77 82 83 25 ext. 33, carole.pelissier@univ-st-etienne.fr
Carole PELISSIER, PhD
About this study
Official 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
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.
- Conditions
- Healthy Volunteers (HV)
- Being tested
- Sleep educational
- Keywords
- Sleep educational program, Alternating 12-hour, day and night shift
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep educationalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep educational | Experimental | Personalized educational program Receives: Behavioral: Sleep educational |
| Control | No intervention | Standard workplace medicine advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (4)
Assess the impact of the sleep education program on sleep quality
The Pittsburgh Sleep Quality Index (PSQI) comprises 24 items, with scores ranging from 0 to 21, where a score > 5 indicates poor sleep quality)
Measured: 6 months
Assess the impact of the sleep education program on participant state of health
Measure of cardiac frequency
Measured: 6 months
Assess the impact of the sleep education program on quality of life
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).
Measured: 6 months
Assess the impact of the sleep education program on accidentology
Number of commuting accidents, workplace accidents, road accidents, near misses related to drowsiness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers (HV)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326579
- Sponsor's protocol ID
- 25PH236
- Other IDs
- 2025-A02584-45
- Acronym
- SLEEPMORE
- Status last verified
- Sep 2026
- First submitted
- 24 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07326579
- Acronym / sponsor ID
- SLEEPMORE / 25PH236
- Conditions
- Healthy Volunteers (HV)
- Keywords
- Sleep educational program, Alternating 12-hour, day and night shift
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep educational | Experimental | Behavioral: Sleep educationalPersonalized educational program |
| Control | No intervention | –Standard workplace medicine advice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep educationalParticipants 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. | Behavioural | Sleep educational |
Primary outcome
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).
4 secondary outcomes
Assess the impact of the sleep education program on sleep quality
Time frame: 6 months
Assess the impact of the sleep education program on participant state of health
Time frame: 6 months
Assess the impact of the sleep education program on quality of life
Time frame: 6 months
Assess the impact of the sleep education program on accidentology
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep educational in people with Healthy Volunteers (HV), run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a 6-month sleep education program (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.