COSQOL: Covert-saccades, Dynamic Visual Acuity and Quality of Life

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT02753179

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vestibular Diseases	Other: Head Impulse Tests Other: Dynamic visual acuity Test (DVAT) Other: VEMPs & VEMPo Other: Dizziness Handicap Inventory Other: Oscillopsia severity questionnaire	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jan 1, 2017

Actual Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bilateral vestibular hypofunction Patients suffering from chronic bilateral vestibular hypofunction.	Other: Head Impulse Tests 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. Other: Dynamic visual acuity Test (DVAT) 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. Other: VEMPs & VEMPo 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. Other: 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 Other: Oscillopsia severity questionnaire Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.

Arm

Intervention/Treatment

Experimental: Bilateral vestibular hypofunction

Patients suffering from chronic bilateral vestibular hypofunction.

Other: Head Impulse Tests

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.

Other: Dynamic visual acuity Test (DVAT)

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.

Other: VEMPs & VEMPo

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.

Other: 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

Other: Oscillopsia severity questionnaire

Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.

Outcome Measures

Primary Outcome Measures

Frequency of covert-saccades [Day 0]
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 [Day 0]
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 [day 0]
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 [day 0]
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 [Day 0]
Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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