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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02753179
Recruitment Status : Completed
First Posted : April 27, 2016
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Frequency of covert-saccades [ Time Frame: 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 :
  1. Quality of life assessed with the Dizziness Handicap Inventory [ Time Frame: 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

  2. Dynamic visual acuity [ Time Frame: 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

  3. Oscillopsia severity questionnaire score [ Time Frame: 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

  4. Latency of covert-saccades [ Time Frame: 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
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753179


Locations
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France
Unité de Neuro-Ophtalmologie Hôpital Neurologique
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Caroline TILIKETE, MD Institut National de la Santé Et de la Recherche Médicale, France
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02753179    
Other Study ID Numbers: 69HCL15_0746
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Keywords provided by Hospices Civils de Lyon:
Bilateral vestibular hypofunction
Video Head Impulse Test
Covert-saccades
Quality of life
Dynamic visual acuity
Additional relevant MeSH terms:
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Vestibular Diseases
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases