EffectivenessHYPNOGER 2NCT07264439
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 study testing VR headset in people with Effectiveness and Virtual Reality, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Effectiveness, Virtual Reality, Hypnotic Scenarios
- What is being tested?
- VR headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2025to 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
- 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.
Who cannot join
- Residents in terminal palliative care.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens University Hospital
Amiens, 80054
Frédéric BLOCH, MD, 03 22 45 57 20, bloch.frederic@chu-amiens.fr
About this study
Official 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
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.
- Conditions
- Effectiveness, Virtual Reality, Hypnotic Scenarios, Hygiene Care, Alzheimer's Disease and Related Disorders (ADRD), Behavioral Disturbances
- Being tested
- VR headset, standard cares
- Keywords
- Effectiveness, virtual reality, hypnotic scenarios, hygiene care, Alzheimer's disease and related disorders (ADRD), behavioral disturbances
- Medical subject headings
- Alzheimer Disease, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR headsetDevice
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 caresOther
standard cares
| Study group | Role | What they receive |
|---|---|---|
| controlled trial | Active comparator | Not described Receives: Other: standard cares |
| VR headset | Experimental | a virtual reality (VR) headset with hypnotic scenarios Receives: Device: VR headset |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of VR headsets
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
Measured: up to 5 weeks
Secondary outcomes (3)
decrease number of patients with behavioral and psychological symptoms in VR headset group
Measured: up to 5 weeks
reduced number of psychotropic drug per patient use in VR headset group
reduced number of psychotropic drug per patient use in VR headset group
Measured: up to 5 weeks
Number of patients with improve quality of life in VH headset group
Number of patients with improve quality of life in VH headset group
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start3 Sep 2025
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EffectivenessStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264439
- Sponsor's protocol ID
- PI2025_843_0010
- Acronym
- HYPNOGER 2
- Status last verified
- Dec 2025
- First submitted
- 18 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07264439
- Acronym / sponsor ID
- HYPNOGER 2 / PI2025_843_0010
- Conditions
- Effectiveness, Virtual Reality, Hypnotic Scenarios, Hygiene Care, Alzheimer's Disease and Related Disorders (ADRD), Behavioral Disturbances
- Keywords
- Effectiveness, virtual reality, hypnotic scenarios, hygiene care, Alzheimer's disease and related disorders (ADRD), behavioral disturbances
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Dec 2025 (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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| controlled trial | Active comparator | Other: standard cares |
| VR headset | Experimental | Device: VR headseta virtual reality (VR) headset with hypnotic scenarios |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Residents in terminal palliative care.
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 |
|---|---|---|
| VR headsetVR 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. | Device | VR headset |
| standard caresstandard cares | Other | controlled trial |
Primary outcome
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
3 secondary outcomes
decrease number of patients with behavioral and psychological symptoms in VR headset group
Time frame: up to 5 weeks
reduced number of psychotropic drug per patient use in VR headset group
Time frame: up to 5 weeks
Number of patients with improve quality of life in VH headset group
Time frame: up to 5 weeks
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 4 Dec 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR headset in people with Effectiveness and Virtual Reality, run by Centre Hospitalier Universitaire, Amiens at 1 site 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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Frédéric Bloch, MD (33+3 22 08 80 51, Bloch.frederic@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of VR headsets (time frame: up to 5 weeks). 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 4 Dec 2025.