Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders: a Monocentric, Randomized, Open-label, Comparative Study.

Conditions
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Insomnia Chronic

Intervention / Treatment
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* Behavioral: Cognitive-behavioural therapy
* Device: HypnoVR® device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cognitive-behavioural therapy<br>Cognitive-behavioural therapy sessions | Behavioral: Cognitive-behavioural therapy<br>* Cognitive-behavioural therapy sessions during 6 weeks of treatment<br>|
| Experimental: Virtual Reality Hypnosis<br>Virtual Reality Hypnosis sessions | Device: HypnoVR® device<br>* HypnoVR® sessions during 6 weeks of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to sleep | Demonstrate a decrease in time to sleep after treatment, by polysomnography | after 6 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Hypnosis, Sleep