Clinical trial NCT04712825: Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders
Official title: Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders: a Monocentric, Randomized, Open-label, Comparative Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Keywords: Virtual reality
Hypnosis
Sleep
Lead sponsor: HypnoVR
Sponsor class: INDUSTRY
First posted: 2021-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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:

1. Patient who, in the judgment of the investigator, has a disease that may preclude participation in study procedures.
2. Minor subject
3. Subject under judicial protection, guardianship or curatorship
4. Inability to give informed information about the subject: demented patients, psychotic patients or follow-up for a psychiatric pathology
5. Unbalanced epilepsy
6. Hearing and/or visual disorders that contraindicate the use of virtual reality headphones
7. Patient with a language barrier
8. Pregnant or breastfeeding patient
9. Subject in period of exclusion (determined by a previous or current study)
10. Patient Refusal
11. Patient currently being treated for depression, alcoholism or drug addiction.
12. Patient using drug treatment for insomnia not stabilized within 2 weeks prior to the start of the study.
13. Patient starting psychological, complementary or alternative medicine treatment for insomnia within 2 weeks prior to the start of the study, or during the study.
14. Patient receiving or having received CBT treatment for insomnia within the last 6 months.
15. Patient diagnosed with sleep apnea, involuntary limb movement, restless legs syndrome.
16. Patient with diagnosed medical conditions that cause insomnia: psychotic disorder, bipolar disorder, dementia, generalized anxiety disorder, panic disorder, manic disorder, schizophrenia, cancer.

Primary outcomes:
measure: Time to sleep
timeFrame: after 6 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Haguenau
country: France
facility: SELARL Respire
Study officials:
References: