AgingPHENOVIRTPSYNCT02544295
Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
A study testing Clinical interview and Virtual reality task in people with Aging and Addiction, run by University of Bordeaux at 1 site in France.
Trial summary
The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders. Read more about this study
- Who is it for?
- Ages 7 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Addiction, Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Clinical interview and Virtual reality task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 590 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being aged between 7 and 75 years
- Having signed written informed consent
Who cannot join
- Having participated to a clinical trial in the previous 3 months
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital of Bordeaux
Bordeaux, 33076
Pierre PHILIP, MD-PhD, +33557820172, pr.philip@free.fr
About this study
The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.
Read the detailed description
Nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : ADHD (Attention Deficit Disorder / Hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. The duration of the study is 8 years.
Type of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle.
Study design:
- standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales,
- a virtual reality task. The primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales).
The secondary outcomes are:
- The comparison of healthy subjects and patients performances
- Tolerance, acceptability to exposure to virtual scenarios.
- Conditions
- Aging, Addiction, Attention Deficit Disorder With Hyperactivity, Sleep Disorders, Anxiety, Depression
- Being tested
- Clinical interview, Virtual reality task
- Medical subject headings
- Behavior, Addictive, Attention Deficit Disorder with Hyperactivity, Sleep Wake Disorders, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical interviewBehavioural
Virtual reality taskBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Clinical interview-Virtual reality task:1 | Experimental | Healthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration Receives: Behavioral: Clinical interview; Behavioral: Virtual reality task |
| Clinical interview-Virtual reality task:2 | Experimental | Patients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration Receives: Behavioral: Clinical interview; Behavioral: Virtual reality task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of the disease
Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)
Measured: 1 day
Secondary outcomes (8)
Sleepiness scale
Scores range from 0 (no sleepiness) to 24 (severe sleepiness)
Measured: 1 day
BDI-II questionnaire
Beck Depression Inventory Scores range from 0 (no depression) to 63 (severe depression)
Measured: 1 day
IDS-R questionnaire
Inventory of Depressive Symptomatology scores range from 0 (no depression) to 84 (severe depression)
Measured: 1 day
Acceptability scale
Scores range from 0 to 36
Measured: 1 day
ASRS
Adult ADHD Self-Report Scale Scores : Four or more positive answers in Part A (6 questions) are indicative of ADHD symptoms.
Measured: 1 day
Physiological parameters: Polysomnography (total sleep time (min))
Measured: 1 night
Physiological parameters: Polysomnography (sleep structure (stage %))
Measured: 1 night
Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre Philip, University of Bordeaux
- Investigators
- Pierre PHILIP, PhD, Principal investigator, University of Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02544295
- Sponsor's protocol ID
- UBXS 2011-02
- Other IDs
- 2011-A01418-33
- Acronym
- PHENOVIRTPSY
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 9 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based-virtual Reality Diagnosis for Neuropsychiatric Diseases and Sleep/Wake Disorders
- ClinicalTrials.gov ID
- NCT02544295
- Acronym / sponsor ID
- PHENOVIRTPSY / UBXS 2011-02
- Conditions
- Aging, Addiction, Attention Deficit Disorder With Hyperactivity, Sleep Disorders, Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- University of BordeauxUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Sep 2015 (estimated)
- 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.
The objective of this research is to develop original virtual reality scenarios and/or new virtual reality equipments to evaluate or diagnose pathologies, such as attention deficit disorders or neuropsychiatric pathologies, addiction, anxiety or depression or pathologies interfering with sleep/wake disorders.
Detailed description
Nature of the trial: without direct individual benefit study conducted in healthy volunteers, patients with attention disorders : ADHD (Attention Deficit Disorder / Hyperactivity) and cognitive aging, addictive disorders, anxiety disorders, depressive disorders or pathologies that interfere with sleep/wake cycle. The duration of the study is 8 years.
Type of trial: Comparison of two parallel groups of healthy volunteers and patients with attention disorders, addictive, anxious, depressive or interfering with sleep/wake cycle.
Study design:
- standardized clinical interview with a sleep specialist, psychiatrist, or psychologist and rating scales,
- a virtual reality task. The primary outcome is to evaluate the diagnosis accuracy and the acceptability of the virtual tool to the referent standard (clinical interview and scales).
The secondary outcomes are:
- The comparison of healthy subjects and patients performances
- Tolerance, acceptability to exposure to virtual scenarios.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical interview-Virtual reality task:1 | Experimental | Behavioral: Clinical interview, Behavioral: Virtual reality taskHealthy controls will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration |
| Clinical interview-Virtual reality task:2 | Experimental | Behavioral: Clinical interview, Behavioral: Virtual reality taskPatients will be assessed by a clinical interview by a psychiatrist, once, 1 day-duration and Virtual reality task, once, 1 day-duration |
Who may qualify
- Ages
- 7 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Being aged between 7 and 75 years
- Having signed written informed consent
Key exclusion criteria (1 listed)
- Having participated to a clinical trial in the previous 3 months
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 |
|---|---|---|
| Clinical interview | Behavioural | Clinical interview-Virtual reality task:1, Clinical interview-Virtual reality task:2 |
| Virtual reality task | Behavioural | Clinical interview-Virtual reality task:1, Clinical interview-Virtual reality task:2 |
Primary outcome
Presence or absence of the disease
Time frame: 1 day
Categorial diagnosis generated by the psychiatrist and by the Virtual reality task (0=absence of disease and 1 = presence of the disease)
8 secondary outcomes
Sleepiness scale
Time frame: 1 day
BDI-II questionnaire
Time frame: 1 day
IDS-R questionnaire
Time frame: 1 day
Acceptability scale
Time frame: 1 day
ASRS
Time frame: 1 day
Physiological parameters: Polysomnography (total sleep time (min))
Time frame: 1 night
Physiological parameters: Polysomnography (sleep structure (stage %))
Time frame: 1 night
Physiological parameters: Polysomnography (Apnea/Hypopnea index and Periodic movements index (events/hr))
Time frame: 1 night
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2015.
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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. This study is not recruiting at the moment.
Pierre PHILIP, PhD principal investigator
University of Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical interview and Virtual reality task in people with Aging and Addiction, run by University of Bordeaux 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 2 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: status not confirmed, as of the sponsor's last update on 9 Sep 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre PHILIP, MD-PhD (+33557820172, pr.philip@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of the disease (time frame: 1 day). 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 Sep 2015.