Status:
COMPLETED
Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders
Lead Sponsor:
HypnoVR
Conditions:
Insomnia Chronic
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief 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. Cognitive ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04712825
Start Date
December 8 2020
End Date
November 30 2022
Last Update
March 2 2023
Active Locations (1)
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1
SELARL Respire
Haguenau, France, 67500