Skip to main content
OpenTrials
Completed

NCT Number: NCT04712825

Effect of Medical Hypnosis in Virtual Reality on Insomnia Disorders

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SELARL Respire

Haguenau, 67500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Treatment and study plan

Cognitive-Behavioural Therapy

Behavioral

Cognitive-behavioural therapy sessions during 6 weeks of treatment

HypnoVR® device

Device

HypnoVR® sessions during 6 weeks of treatment

Primary outcomes

  1. Time to sleep

    Time frame: after 6 weeks of treatment

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

Sponsors and collaborators

Lead sponsor

HypnoVR

Industry

Registry information

Official study title

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

Acronym: EMERITE

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Mar 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.