Sleep DisorderLucioleNCT07395323
Impact of Relaxation Sessions Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts
A study testing Arm 1: Experimental (VR) Intervention: Virtual reality sessions in people with Sleep Disorder, run by Centre Hospitalier St Anne.
Trial summary
This project aims to evaluate the impact of relaxation sessions conducted using a virtual reality device on the sleep quality of night-shift healthcare workers. The intervention specifically targets the immediate post-night-shift period, a critical time for recovery, by offering immersive guided relaxation experiences… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disorder
- What is being tested?
- Arm 1: Experimental (VR) Intervention: Virtual reality sessions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- State-certified nurse or nursing assistant (GHU, GHPG staff)
- Regularly working night shifts and on duty in the units
- Age 18 years and over
- Informed individuals who have signed written consent
- Individuals affiliated with a social security scheme and must be able to understand and read French.
Who cannot join
- No possibility of follow-up (subjects on fixed-term contracts, ongoing transfers, student reinforcements, etc.)
- Subjects with insufficient command of the French language, preventing them from taking the tests
- Pregnant or breastfeeding women (disruption of the sleep cycle), or women with young children.
- Individuals with a pacemaker or any other implanted medical device, unless medically advised otherwise (due to the radio-magnetic waves emitted by the virtual reality headset)
- Individuals with epilepsy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Impact of Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts
This project aims to evaluate the impact of relaxation sessions conducted using a virtual reality device on the sleep quality of night-shift healthcare workers. The intervention specifically targets the immediate post-night-shift period, a critical time for recovery, by offering immersive guided relaxation experiences designed to reduce anxiety and promote both mental and physiological relaxation.
Read the detailed description
Paramedical staff working night shifts are particularly exposed to sleep disorders and psychological difficulties due to the length and organization of their working hours. The ANSES report highlights the central role of anxiety, both as a consequence of night work and as a factor that worsens sleep disturbances.
In response to this situation, the GHU Directorate of Nursing, in collaboration with Occupational Health, the CHRONOS team, and the pain specialist physician, has initiated a reflection on preventive actions aimed at better addressing the vulnerability of healthcare professionals. The objective is to provide concrete responses to psychological distress and the high levels of stress experienced by healthcare workers, which have been further intensified by the health crisis.
Within this framework, it is proposed to specifically address immediate post-night-shift sleep disturbances by implementing a relaxation program using a virtual reality application. This non-pharmacological approach aims to reduce anxiety and improve recovery among paramedical professionals working night shifts.
- Conditions
- Sleep Disorder
- Being tested
- Arm 1: Experimental (VR) Intervention: Virtual reality sessions, Arm 2: Control (No VR / Standard Care)
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm 1: Experimental (VR) Intervention: Virtual reality sessionsDevice
During the virtual reality period (1 month), the participant receives a VR headset and an actigrapher, provided by a Registered Nurse Practitioner (RNP). A training session is organized and scheduled following enrollment. The participant will keep the VR headset and actigrapher at home for one month. The devices will be collected by the night shift supervisor at the end of the usage period. A paper sleep diary will be provided to assess sleep quality.
Arm 2: Control (No VR / Standard Care)Device
Intervention: No virtual reality or standard care
Description: Participants do not undergo virtual reality sessions during this period.
The sleep-wake rhythm will be analyzed using an actimeter.
| Study group | Role | What they receive |
|---|---|---|
| control comparator. | Active comparator | The participant receives the actigraph again and maintains their usual bedtime and sleep-onset routine, completing the paper sleep diary for sleep quality after each waking.
The PSQI scale is measured on the first day (D1) and again after the last night (D30).
The sleep-wake rhythm will be analyzed using an actimeter. Receives: Device: Arm 2: Control (No VR / Standard Care) |
| Arm 1: Experimental (VR) | Experimental | Intervention: Virtual reality sessions
Description: Participants undergo virtual reality sessions during this period. The sleep-wake rhythm will be analyzed using an actimeter. The sleep-wake rhythm will be analyzed using an actimeter. Receives: Device: Arm 1: Experimental (VR) Intervention: Virtual reality sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the evolution of sleep quality of paramedical professionals assessed by the PSQI scale, with or without intervention, (cross-over design).
The PSQI provides a score ranging from 0 to 3 for each of the seven components, as well as an overall sleep quality score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
The PSQI self-administered questionnaire is used in research and clinical practice to assess sleep quality before and after pharmacological treatment or behavioral therapy in order to measure the impact of the intervention on individuals' sleep.
Measured: 15 months
Secondary outcomes (3)
Severity of sleep disorders: ISI,
Score Total: 0 to 28
Interpretation
0-7: No clinically significant insomnia
8-14: Mild insomnia (subthreshold)
15-21: Moderate insomnia
22-28: Severe insomnia
Measured: 15 months
Level of Anxiety: GAD-7
Interpretation
0-4: Minimal anxiety
5-9: Mild anxiety
10-14: Moderate anxiety
Measured: 15 months
Level of anxiety and depression: QIDS
Total: 0 to 27
Interpretation
0-5: No depression
6-10: Mild depression
11-15: Moderate depression
16-20: Severe depression
21-27: Very severe depression
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Arm 1: Experimental (VR) Intervention: Virtual reality sessions Description: Participants undergo virtual reality sessions during this period. Arm 2: Control (No VR) Intervention: No virtual reality or standard care Description: Participants do not undergo virtual reality sessions during this period.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07395323
- Sponsor's protocol ID
- D24-P018
- Acronym
- Luciole
- Status last verified
- Nov 2025
- First submitted
- 22 Dec 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Using a Virtual Reality Application on the Sleep Quality of Caregivers Working Night Shifts
- ClinicalTrials.gov ID
- NCT07395323
- Acronym / sponsor ID
- Luciole / D24-P018
- Conditions
- Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 9 Feb 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.
This project aims to evaluate the impact of relaxation sessions conducted using a virtual reality device on the sleep quality of night-shift healthcare workers. The intervention specifically targets the immediate post-night-shift period, a critical time for recovery, by offering immersive guided relaxation experiences designed to reduce anxiety and promote both mental and physiological relaxation.
Detailed description
Paramedical staff working night shifts are particularly exposed to sleep disorders and psychological difficulties due to the length and organization of their working hours. The ANSES report highlights the central role of anxiety, both as a consequence of night work and as a factor that worsens sleep disturbances.
In response to this situation, the GHU Directorate of Nursing, in collaboration with Occupational Health, the CHRONOS team, and the pain specialist physician, has initiated a reflection on preventive actions aimed at better addressing the vulnerability of healthcare professionals. The objective is to provide concrete responses to psychological distress and the high levels of stress experienced by healthcare workers, which have been further intensified by the health crisis.
Within this framework, it is proposed to specifically address immediate post-night-shift sleep disturbances by implementing a relaxation program using a virtual reality application. This non-pharmacological approach aims to reduce anxiety and improve recovery among paramedical professionals working night shifts.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm 1: Experimental (VR) Intervention: Virtual reality sessions Description: Participants undergo virtual reality sessions during this period. Arm 2: Control (No VR) Intervention: No virtual reality or standard care Description: Participants do not undergo virtual reality sessions during this period.
| Arm | Type | Receives |
|---|---|---|
| control comparator. | Active comparator | Device: Arm 2: Control (No VR / Standard Care)The participant receives the actigraph again and maintains their usual bedtime and sleep-onset routine, completing the paper sleep diary for sleep quality after each waking. The PSQI scale is measured on the first day (D1) and again after the last night (D30). The sleep-wake rhythm will be analyzed using an actimeter. |
| Arm 1: Experimental (VR) | Experimental | Device: Arm 1: Experimental (VR) Intervention: Virtual reality sessionsIntervention: Virtual reality sessions Description: Participants undergo virtual reality sessions during this period. The sleep-wake rhythm will be analyzed using an actimeter. The sleep-wake rhythm will be analyzed using an actimeter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- State-certified nurse or nursing assistant (GHU, GHPG staff)
- Regularly working night shifts and on duty in the units
- Age 18 years and over
- Informed individuals who have signed written consent
- Individuals affiliated with a social security scheme and must be able to understand and read French.
Key exclusion criteria (5 listed)
- No possibility of follow-up (subjects on fixed-term contracts, ongoing transfers, student reinforcements, etc.)
- Subjects with insufficient command of the French language, preventing them from taking the tests
- Pregnant or breastfeeding women (disruption of the sleep cycle), or women with young children.
- Individuals with a pacemaker or any other implanted medical device, unless medically advised otherwise (due to the radio-magnetic waves emitted by the virtual reality headset)
- Individuals with epilepsy.
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 |
|---|---|---|
| Arm 1: Experimental (VR) Intervention: Virtual reality sessionsDuring the virtual reality period (1 month), the participant receives a VR headset and an actigrapher, provided by a Registered Nurse Practitioner (RNP). A training session is organized and scheduled following enrollment. The participant will keep the VR headset and actigrapher at home for one month. The devices will be collected by the night shift supervisor at the end of the usage period. A paper sleep diary will be provided to assess sleep quality. | Device | Arm 1: Experimental (VR) |
| Arm 2: Control (No VR / Standard Care)Intervention: No virtual reality or standard care Description: Participants do not undergo virtual reality sessions during this period. The sleep-wake rhythm will be analyzed using an actimeter. | Device | control comparator. |
Primary outcome
Compare the evolution of sleep quality of paramedical professionals assessed by the PSQI scale, with or without intervention, (cross-over design).
Time frame: 15 months
The PSQI provides a score ranging from 0 to 3 for each of the seven components, as well as an overall sleep quality score ranging from 0 to 21, with higher scores indicating poorer sleep quality. The PSQI self-administered questionnaire is used in research and clinical practice to assess sleep quality before and after pharmacological treatment or behavioral therapy in order to measure the impact of the intervention on individuals' sleep.
3 secondary outcomes
Severity of sleep disorders: ISI,
Time frame: 15 months
Level of Anxiety: GAD-7
Time frame: 15 months
Level of anxiety and depression: QIDS
Time frame: 15 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 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Arm 1: Experimental (VR) Intervention: Virtual reality sessions in people with Sleep Disorder, run by Centre Hospitalier St Anne.
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 5 inclusion and 5 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 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Pierre A GEOFFROY, PU-PH (01.58.11.12.40, pa.geoffroy@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the evolution of sleep quality of paramedical professionals assessed by the PSQI scale, with or without intervention, (cross-over design). (time frame: 15 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 9 Feb 2026.