Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders

Insomnia Chronic Clinical Trial

— EMERITE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712825
• Other study ID #: HYPNOVR-RIPH-2020-2
• Status: Completed
• Phase: N/A
• Start date: December 8, 2020
• Est. completion date: November 30, 2022

Study information

• Verified date: March 2023
• Source: HypnoVR
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia Chronic
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Cognitive-behavioural therapy
Cognitive-behavioural therapy sessions during 6 weeks of treatment

Device:
• HypnoVR® device
HypnoVR® sessions during 6 weeks of treatment

Locations

Country	Name	City	State
France	SELARL Respire	Haguenau

Sponsors (1)

Lead Sponsor	Collaborator
HypnoVR

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to sleep	Demonstrate a decrease in time to sleep after treatment, by polysomnography	after 6 weeks of treatment