Insomnia ChronicEMERITENCT04712825
Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders
A study testing Cognitive-behavioural therapy and HypnoVR® device in people with Insomnia Chronic, run by HypnoVR at 1 site in France.
Trial summary
The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Insomnia Chronic
- What is being tested?
- Cognitive-behavioural therapy and HypnoVR® device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2020to 30 Nov 2022
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patient suffering from insomnia as defined in the Diagnostic and Statistical Manual of Mental Disorders V (DMS-V) and the International Classification of Sleep Disorders.
Who cannot join
- Patient who, in the judgment of the investigator, has a disease that may preclude participation in study procedures.
- Minor subject
- Subject under judicial protection, guardianship or curatorship
- Inability to give informed information about the subject: demented patients, psychotic patients or follow-up for a psychiatric pathology
- Unbalanced epilepsy
- Hearing and/or visual disorders that contraindicate the use of virtual reality headphones
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- Patient with a language barrier
- Pregnant or breastfeeding patient
- Subject in period of exclusion (determined by a previous or current study)
- Patient Refusal
- Patient currently being treated for depression, alcoholism or drug addiction.
- Patient using drug treatment for insomnia not stabilized within 2 weeks prior to the start of the study.
- Patient starting psychological, complementary or alternative medicine treatment for insomnia within 2 weeks prior to the start of the study, or during the study.
- Patient receiving or having received CBT treatment for insomnia within the last 6 months.
- Patient diagnosed with sleep apnea, involuntary limb movement, restless legs syndrome.
- Patient with diagnosed medical conditions that cause insomnia: psychotic disorder, bipolar disorder, dementia, generalized anxiety disorder, panic disorder, manic disorder, schizophrenia, cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders: a Monocentric, Randomized, Open-label, Comparative Study.
The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety.
Cognitive and Behavioral Therapy (CBT) is today the reference treatment recommended by the "Haute Autorité de Santé" and the American College of Physicians for chronic insomnia. Today, however, few patients use CBT treatment due to the lack of trained practitioners, the cost of non-reimbursed sessions and the time and involvement that these sessions require.
Several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. The hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in patients suffering from insomnia disorders.
- Conditions
- Insomnia Chronic
- Being tested
- Cognitive-behavioural therapy, HypnoVR® device
- Keywords
- Virtual reality, Hypnosis, Sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-behavioural therapyBehavioural
Cognitive-behavioural therapy sessions during 6 weeks of treatment
HypnoVR® deviceDevice
HypnoVR® sessions during 6 weeks of treatment
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioural therapy | Active comparator | Cognitive-behavioural therapy sessions Receives: Behavioral: Cognitive-behavioural therapy |
| Virtual Reality Hypnosis | Experimental | Virtual Reality Hypnosis sessions Receives: Device: HypnoVR® device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to sleep
Demonstrate a decrease in time to sleep after treatment, by polysomnography
Measured: after 6 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start8 Dec 2020
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia ChronicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- HypnoVR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04712825
- Sponsor's protocol ID
- HYPNOVR-RIPH-2020-2
- Acronym
- EMERITE
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2020
- Last updated
- 2 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders: a Monocentric, Randomized, Open-label, Comparative Study.
- ClinicalTrials.gov ID
- NCT04712825
- Acronym / sponsor ID
- EMERITE / HYPNOVR-RIPH-2020-2
- Conditions
- Insomnia Chronic
- Keywords
- Virtual reality, Hypnosis, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- HypnoVRIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Jan 2021 (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.
The prevalence of chronic insomnia is 13.3% in France in 2019 (8.9 million). The consequences for these people are multiple: drowsiness, memory problems, difficulty concentrating, anxiety.
Cognitive and Behavioral Therapy (CBT) is today the reference treatment recommended by the "Haute Autorité de Santé" and the American College of Physicians for chronic insomnia. Today, however, few patients use CBT treatment due to the lack of trained practitioners, the cost of non-reimbursed sessions and the time and involvement that these sessions require.
Several clinical trials have shown beneficial effects of hypnotherapy on sleep disorders. The hypothesis of this work is that the use of hypnosis in virtual reality improves sleep time in patients suffering from insomnia disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioural therapy | Active comparator | Behavioral: Cognitive-behavioural therapyCognitive-behavioural therapy sessions |
| Virtual Reality Hypnosis | Experimental | Device: HypnoVR® deviceVirtual Reality Hypnosis sessions |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Patient suffering from insomnia as defined in the Diagnostic and Statistical Manual of Mental Disorders V (DMS-V) and the International Classification of Sleep Disorders.
Key exclusion criteria (16 listed)
- Patient who, in the judgment of the investigator, has a disease that may preclude participation in study procedures.
- Minor subject
- Subject under judicial protection, guardianship or curatorship
- Inability to give informed information about the subject: demented patients, psychotic patients or follow-up for a psychiatric pathology
- Unbalanced epilepsy
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 |
|---|---|---|
| Cognitive-behavioural therapyCognitive-behavioural therapy sessions during 6 weeks of treatment | Behavioural | Cognitive-behavioural therapy |
| HypnoVR® deviceHypnoVR® sessions during 6 weeks of treatment | Device | Virtual Reality Hypnosis |
Primary outcome
Time to sleep
Time frame: after 6 weeks of treatment
Demonstrate a decrease in time to sleep after treatment, by polysomnography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioural therapy and HypnoVR® device in people with Insomnia Chronic, run by HypnoVR 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 1 inclusion and 16 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: finished, as of the sponsor's last update on 2 Mar 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sleep (time frame: after 6 weeks of treatment). 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 2 Mar 2023.