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

Primary Purpose

Insomnia Chronic

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Cognitive-behavioural therapy

HypnoVR® device

About this trial

This is an interventional treatment trial for Insomnia Chronic focused on measuring Virtual reality, Hypnosis, Sleep

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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:

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.

Sites / Locations

SELARL Respire

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cognitive-behavioural therapy

Virtual Reality Hypnosis

Arm Description

Cognitive-behavioural therapy sessions

Virtual Reality Hypnosis sessions

Outcomes

Primary Outcome Measures

Time to sleep

Demonstrate a decrease in time to sleep after treatment, by polysomnography

Secondary Outcome Measures

Full Information

NCT ID

NCT04712825

First Posted

December 8, 2020

Last Updated

March 1, 2023

Sponsor

HypnoVR

1. Study Identification

Unique Protocol Identification Number

NCT04712825

Brief Title

Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders

Acronym

EMERITE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

December 8, 2020 (Actual)

Primary Completion Date

November 30, 2022 (Actual)

Study Completion Date

November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HypnoVR

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia Chronic

Keywords

Virtual reality, Hypnosis, Sleep

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognitive-behavioural therapy

Arm Type

Active Comparator

Arm Description

Cognitive-behavioural therapy sessions

Arm Title

Virtual Reality Hypnosis

Arm Type

Experimental

Arm Description

Virtual Reality Hypnosis sessions

Intervention Type

Behavioral

Intervention Name(s)

Cognitive-behavioural therapy

Intervention Description

Cognitive-behavioural therapy sessions during 6 weeks of treatment

Intervention Type

Device

Intervention Name(s)

HypnoVR® device

Intervention Description

HypnoVR® sessions during 6 weeks of treatment

Primary Outcome Measure Information:

Title

Time to sleep

Description

Demonstrate a decrease in time to sleep after treatment, by polysomnography

Time Frame

after 6 weeks of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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: 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.

Facility Information:

Facility Name

SELARL Respire

City

Haguenau

ZIP/Postal Code

67500

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Yes

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Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders

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