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

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia Chronic
• Intervention / Treatment: Behavioral: Cognitive-behavioural therapy; Device: HypnoVR® device

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Haguenau, France, 67500
    • SELARL Respire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: HypnoVR

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): November 30, 2022

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2023
• Last Update Submitted That Met QC Criteria: March 1, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Sleep; Hypnosis; Virtual reality
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: HYPNOVR-RIPH-2020-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No