As of February 20, 2026, a newly registered ClinicalTrials.gov record outlines a study on relaxing sessions delivered via virtual reality to support sleep among caregivers on night shifts. The record lists Sleep Disorder as the condition and describes two arms. Arm 1 is the Experimental VR Intervention with virtual reality sessions; Arm 2 is the Control with No VR or Standard Care. The sponsor is Centre Hospitalier St Anne and the trial status is Not yet recruiting. The registry entry signals regulatory and clinical interest in digital relaxation tools as potential nonpharmacologic options for sleep disturbances in caregiver populations.
What changed in the trial record?
The registry entry provides a snapshot of a trial plan to evaluate the impact of relaxing sessions delivered via virtual reality on sleep quality in a caregiver population that works night shifts. The listed condition is Sleep Disorder. The design describes two arms: Arm 1, Experimental VR Intervention with virtual reality sessions, and Arm 2, Control with No VR or Standard Care. The sponsor is Centre Hospitalier St Anne and the status is Not yet recruiting. This means there are no results at this time and updates will appear as the study progresses under regulatory reporting standards.
What is being tested and how is it structured?
The intervention is described as virtual reality sessions used for relaxation. The comparator is standard care without virtual reality. The two arm structure allows an assessment of whether a digital relaxation modality can influence sleep related outcomes in caregivers on night shifts. The registry excerpt does not include endpoints, sample size, or statistical analysis details. The description aligns with a medical device oriented approach to non pharmacologic therapy, and future documentation will be needed to establish the device’s intended use and safety profile under regulatory expectations.
What is the role of the sponsor and the setting?
The sponsor Centre Hospitalier St Anne is a hospital based organization which suggests access to real world caregiver populations for study enrollment. The setting underscores the importance of privacy, data protection, and device handling in a clinical environment. No results are reported yet and the trial status remains Not yet recruiting.
What are the regulatory implications for this trial?
The registry entry signals an exploration of a digital relaxation tool within a medical device framework. If the study proceeds, documentation will need to address the device description, intended use, risk management, and performance or safety outcomes in line with regulatory expectations. The Not yet recruiting status means no published safety or efficacy data are available. Stakeholders should track updates from the sponsor and from ClinicalTrials.gov to understand how the device is positioned and what future regulatory filings may require.
What safety considerations apply to this study?
Current registry information does not provide safety outcomes. In line with medical device regulation, future disclosures should include an assessment of risks associated with the virtual reality intervention, potential discomfort, simulation related issues, cognitive load, data privacy concerns, and device related hazards. A formal risk analysis and mitigation plan would be expected as the study advances and findings emerge.
Conclusion and implications for readers
The registry confirms a regulatory oriented inquiry into non pharmacologic sleep support for night shift caregivers using virtual reality. Regulators, healthcare providers, and device developers should monitor the sponsor’s updates and the registry postings for new information on endpoints, safety data, and regulatory filings. If the study progresses to enrollment and results, the information could contribute to decisions about non drug approaches to sleep disturbances in caregiver populations and to risk management strategies in related devices.
FAQs
- 1. What is the purpose of this trial This registry entry describes a plan to test if virtual reality relaxation sessions can affect sleep quality in caregivers working night shifts.
- 2. What are the study arms Arm 1 is the Experimental VR Intervention with virtual reality sessions, and Arm 2 is the Control with No VR or Standard Care.
- 3. Who is sponsoring the study The sponsor listed is Centre Hospitalier St Anne.
Disclaimer: This article is for professionals and informational only. It is not legal advice. For legal counsel, consult appropriate experts.