Evaluation of the Effectiveness of Virtual Reality Headsets With Hypnotic Scenarios for Hygiene Care in Patients With Alzheimer's Disease or Related Disorders With Behavioral Disturbances (HYPNOGER 2)

December 2, 2025 updated by: Centre Hospitalier Universitaire, Amiens

Evaluation of the Effectiveness of Virtual Reality Headsets With Hypnotic Scenarios for Hygiene Care in Patients With Alzheimer's Disease or Related Disorders (ADRD) With Behavioral Disturbances

A device combining a virtual reality (VR) headset with hypnotic scenarios may represent an effective tool to reduce anxiety and opposition during hygiene care in patients with neurocognitive disorders presenting with behavioral and psychological symptoms.

The primary objective of this project is to assess the feasibility and effectiveness of VR headsets with hypnotic scenarios compared with standard care in patients with ADRD presenting behavioral disturbances during hygiene care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Residents of the St-Victor center (CHU Amiens-Picardie), including nursing home units, reinforced care units, and long-term care units;
  • Patients diagnosed with ADRD presenting opposition or agitation during hygiene and toileting care;
  • Affiliation to a social security scheme,
  • Informed consent signed by the patient or legal representative.

Exclusion Criteria:

  • Residents in terminal palliative care.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: controlled trial
Other: standard cares
standard cares
Experimental: VR headset
a virtual reality (VR) headset with hypnotic scenarios
Device: VR headset
VR headset enabling the management of hypnotic scenarios. The headset will project immersive 3D images and deliver a hypnotic narrative, thus combining VR and hypnosis-based techniques. This intervention will be applied during hygiene and toileting care and compared to standard behavioral management traditionally used in the structures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness of VR headsets
Time Frame: up to 5 weeks

Effectiveness of VR headsets delivering hypnotic scenarios versus standard cares in older adults with ADRD and behavioral disturbances (opposition or agitation), with the aim of reducing apprehension, pain, anxiety, and resistance during hygiene and toileting care.

Evaluation with EPADE sclae
up to 5 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
decrease number of patients with behavioral and psychological symptoms in VR headset group
Time Frame: up to 5 weeks
up to 5 weeks
reduced number of psychotropic drug per patient use in VR headset group
Time Frame: up to 5 weeks
reduced number of psychotropic drug per patient use in VR headset group
up to 5 weeks
Number of patients with improve quality of life in VH headset group
Time Frame: up to 5 weeks
Number of patients with improve quality of life in VH headset group
up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2025

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

December 2, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

December 2, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI2025_843_0010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Virtual Reality

Clinical Trials on standard cares

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe