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Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders (EMERITE)

H

HypnoVR

Status

Completed

Conditions

Insomnia Chronic

Treatments

Behavioral: Cognitive-behavioural therapy
Device: HypnoVR® device

Study type

Interventional

Funder types

Industry

Identifiers

NCT04712825
HYPNOVR-RIPH-2020-2

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Cognitive-behavioural therapy
Active Comparator group
Description:
Cognitive-behavioural therapy sessions
Treatment:
Behavioral: Cognitive-behavioural therapy
Virtual Reality Hypnosis
Experimental group
Description:
Virtual Reality Hypnosis sessions
Treatment:
Device: HypnoVR® device

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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