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Completed

NCT Number: NCT02753179

Covert-saccades, Dynamic Visual Acuity and Quality of Life

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.

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Key information

Conditions

Vestibular Diseases Ear Diseases Labyrinth Diseases Otorhinolaryngologic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité de Neuro-Ophtalmologie Hôpital Neurologique

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Head Impulse Tests

Other

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.

Dynamic visual acuity Test (DVAT)

Other

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.

VEMPs & VEMPo

Other

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.

Dizziness Handicap Inventory

Other

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

Oscillopsia severity questionnaire

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COSQOL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 27, 2016
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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