NCT05628220

Brief Summary

Evaluation of a virtual reality desensitization protocol on subjects with severe motion sickness and study of the role of the emotional component on the effectiveness of the therapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Study Start

First participant enrolled

January 10, 2018

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 28, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

November 28, 2022

Status Verified

August 1, 2022

Enrollment Period

5.1 years

First QC Date

September 8, 2022

Last Update Submit

November 24, 2022

Conditions

Keywords

vestibular systempostureanxietynauseamotion sicknessvisually induced motion sickness

Outcome Measures

Primary Outcomes (2)

  • motion sickness severity

    simulator sickness questionnaire (0-64)

    day 0 (day before the first session of rehabilitation)

  • motion sickness severity

    simulator sickness questionnaire (0-64)

    day 30 (day after the end of rehabilitation)

Secondary Outcomes (4)

  • Emotion

    day 0 (day before the first session of rehabilitation)

  • Emotion

    day 30 (day after the end of rehabilitation)

  • Posture

    day 0 (day before the first session of rehabilitation)

  • Posture

    day 30 (day after the end of rehabilitation)

Study Arms (1)

Cohort of motion sickness

OTHER

one group of patient

Other: physiotherapy

Interventions

rehabilitation through using session of virtual reality desensitization

Cohort of motion sickness

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suffering from motion sickness inducing a functional disability requiring a change in the mode of travel, or suffering from motion sickness disabling to exercise a leisure or professional activity involving a mode of locomotion.

You may not qualify if:

  • Pregnant woman
  • History of severe ENT or ophthalmologic pathologies.
  • Chronic treatment with an anticholinergic or anti-histamine medication.
  • Participating in another biomedical research protocol during the same period
  • Person under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Caen University Hospital

Caen, 14033, France

RECRUITING

Frédéric Xavier

Vitrolles, 13127, France

RECRUITING

Related Links

MeSH Terms

Conditions

Motion SicknessAnxiety DisordersNausea

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsMental DisordersSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • stephane BESNARD, Md,PhD

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

stephane besnard, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: one cohort of patients suffering from motion sickness
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2022

First Posted

November 28, 2022

Study Start

January 10, 2018

Primary Completion

February 28, 2023

Study Completion

February 28, 2023

Last Updated

November 28, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations