Covert-saccades, Dynamic Visual Acuity and Quality of Life (COSQOL)
Primary Purpose
Vestibular Diseases
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Head Impulse Tests
Dynamic visual acuity Test (DVAT)
VEMPs & VEMPo
Dizziness Handicap Inventory
Oscillopsia severity questionnaire
Sponsored by
About this trial
This is an interventional basic science trial for Vestibular Diseases focused on measuring Bilateral vestibular hypofunction, Video Head Impulse Test, Covert-saccades, Quality of life, Dynamic visual acuity
Eligibility Criteria
Inclusion Criteria:
Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria
- Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
- Pathologic Head-impulse test
- VOR gain of <0.25 on rotatory chair tests
- Disorder present for over 6 month
- Comprehension of the experiments instructions
- Patient consent
Exclusion Criteria:
- Corrected Visual Acuity lower than 5/10
- Other conditions leading to oscillopsia or ataxia
- Oculomotor palsy, ocular instability in primary position
- Cervical rachis pathology with instability
- Cochlear Implants
- Non-stabilized medical disease
- Pregnant women
- Patients under tutelage
Sites / Locations
- Unité de Neuro-Ophtalmologie Hôpital Neurologique
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral vestibular hypofunction
Arm Description
Patients suffering from chronic bilateral vestibular hypofunction.
Outcomes
Primary Outcome Measures
Frequency of covert-saccades
Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.
Secondary Outcome Measures
Quality of life assessed with the Dizziness Handicap Inventory
Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100
Dynamic visual acuity
Dynamic visual acuity is a measure of threshold for binocular reading of letters that are presented on a screen during head impulse test
Oscillopsia severity questionnaire score
Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances. A mean item score gives an oscillopsia severity score ranging from 1 to 5, yielding to a total score ranging from 0 to 45
Latency of covert-saccades
Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade
Full Information
NCT ID
NCT02753179
First Posted
April 25, 2016
Last Updated
January 13, 2017
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02753179
Brief Title
Covert-saccades, Dynamic Visual Acuity and Quality of Life
Acronym
COSQOL
Official Title
Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Diseases
Keywords
Bilateral vestibular hypofunction, Video Head Impulse Test, Covert-saccades, Quality of life, Dynamic visual acuity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral vestibular hypofunction
Arm Type
Experimental
Arm Description
Patients suffering from chronic bilateral vestibular hypofunction.
Intervention Type
Other
Intervention Name(s)
Head Impulse Tests
Intervention Description
Head Impulse Tests are performed by the clinician who holds the patient's head in his hands, while he is looking straight at an earth-fixed target; then by turning the patient's head abruptly and unpredictably to the left or right, up or down through a small angle (only 10-20 degrees - not a large angle). 20 impulses in each directions (6) will be performed.
Intervention Type
Other
Intervention Name(s)
Dynamic visual acuity Test (DVAT)
Intervention Description
Dynamic visual acuity Test (DVAT) assesses visual acuity during head movement relative to baseline static visual acuity. DVA will be assessed actively during self-generated rotations of the head in different directions.
Intervention Type
Other
Intervention Name(s)
VEMPs & VEMPo
Intervention Description
VEMPs & VEMPo are sound evoked muscular contractions of the neck or eye. They are recorded using an evoked response computer, a sound generator, and surface electrodes to pick up neck or eye muscle activation.
Intervention Type
Other
Intervention Name(s)
Dizziness Handicap Inventory
Intervention Description
Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100
Intervention Type
Other
Intervention Name(s)
Oscillopsia severity questionnaire
Intervention Description
Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.
Primary Outcome Measure Information:
Title
Frequency of covert-saccades
Description
Frequency of covert saccades corresponds to the total amount of covert-saccades divided by the total amount of head impulse tests multiplied by 100.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Quality of life assessed with the Dizziness Handicap Inventory
Description
Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100
Time Frame
Day 0
Title
Dynamic visual acuity
Description
Dynamic visual acuity is a measure of threshold for binocular reading of letters that are presented on a screen during head impulse test
Time Frame
day 0
Title
Oscillopsia severity questionnaire score
Description
Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances. A mean item score gives an oscillopsia severity score ranging from 1 to 5, yielding to a total score ranging from 0 to 45
Time Frame
day 0
Title
Latency of covert-saccades
Description
Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria
Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
Pathologic Head-impulse test
VOR gain of <0.25 on rotatory chair tests
Disorder present for over 6 month
Comprehension of the experiments instructions
Patient consent
Exclusion Criteria:
Corrected Visual Acuity lower than 5/10
Other conditions leading to oscillopsia or ataxia
Oculomotor palsy, ocular instability in primary position
Cervical rachis pathology with instability
Cochlear Implants
Non-stabilized medical disease
Pregnant women
Patients under tutelage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline TILIKETE, MD
Organizational Affiliation
Institut National de la Santé Et de la Recherche Médicale, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unité de Neuro-Ophtalmologie Hôpital Neurologique
City
Bron
ZIP/Postal Code
69500
Country
France
12. IPD Sharing Statement
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Covert-saccades, Dynamic Visual Acuity and Quality of Life
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