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NCT Number: NCT07264439

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

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.

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Key information

Conditions

Effectiveness Alzheimer Disease Alzheimer's Disease and Related Disorders (ADRD) Behavioral Disturbances Brain Diseases Central Nervous System Diseases Dementia Hygiene Care Hypnotic Scenarios Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Virtual Reality

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

VR headset

Device

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.

standard cares

Other

standard cares

Primary outcomes

  1. 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

Secondary outcomes

  1. decrease number of patients with behavioral and psychological symptoms in VR headset group

    Time frame: up to 5 weeks

  2. 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

  3. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Frédéric Bloch, MD

CONTACT

[email protected]

33+3 22 08 80 51

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: HYPNOGER 2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

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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