NCT04712825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

December 8, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

March 2, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

December 8, 2020

Last Update Submit

March 1, 2023

Conditions

Insomnia Chronic

Keywords

Virtual realityHypnosisSleep

Outcome Measures

Primary Outcomes (1)

  • Time to sleep

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

    after 6 weeks of treatment

Study Arms (2)

Cognitive-behavioural therapy

ACTIVE COMPARATOR

Cognitive-behavioural therapy sessions

Behavioral: Cognitive-behavioural therapy

Virtual Reality Hypnosis

EXPERIMENTAL

Virtual Reality Hypnosis sessions

Device: HypnoVR® device

Interventions

Cognitive-behavioural therapyBEHAVIORAL

Cognitive-behavioural therapy sessions during 6 weeks of treatment

Cognitive-behavioural therapy
HypnoVR® deviceDEVICE

HypnoVR® sessions during 6 weeks of treatment

Virtual Reality Hypnosis

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SELARL Respire

Haguenau, 67500, France

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

January 15, 2021

Study Start

December 8, 2020

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

March 2, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share
Shared Documents
CSR

Locations

FR(1)