Vestibular DiseasesCOSQOLNCT02753179
Covert-saccades, Dynamic Visual Acuity and Quality of Life
A study testing Head Impulse Tests, Dynamic visual acuity Test (DVAT) and VEMPs & VEMPo in people with Vestibular Diseases, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Vestibular Diseases
- What is being tested?
- Head Impulse Tests, Dynamic visual acuity Test (DVAT) and VEMPs & VEMPo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- May 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades
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.
- Conditions
- Vestibular Diseases
- Being tested
- Head Impulse Tests, Dynamic visual acuity Test (DVAT), VEMPs & VEMPo, Dizziness Handicap Inventory, Oscillopsia severity questionnaire
- Keywords
- Bilateral vestibular hypofunction, Video Head Impulse Test, Covert-saccades, Quality of life, Dynamic visual acuity
- Medical subject headings
- Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head Impulse TestsOther
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 & VEMPoOther
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 InventoryOther
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 questionnaireOther
Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.
| Study group | Role | What they receive |
|---|---|---|
| Bilateral vestibular hypofunction | Experimental | Patients suffering from chronic bilateral vestibular hypofunction. Receives: Other: Head Impulse Tests; Other: Dynamic visual acuity Test (DVAT); Other: VEMPs & VEMPo; Other: Dizziness Handicap Inventory; Other: Oscillopsia severity questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (4)
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
Measured: Day 0
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
Measured: day 0
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
Measured: day 0
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vestibular DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline TILIKETE, MD, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02753179
- Sponsor's protocol ID
- 69HCL15_0746
- Acronym
- COSQOL
- Status last verified
- Aug 2025
- First submitted
- 25 Apr 2016
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Hermann R, Pelisson D, Dumas O, Urquizar C, Truy E, Tilikete C. Are Covert Saccade Functionally Relevant in Vestibular Hypofunction? Cerebellum. 2018 Jun;17(3):300-307. doi: 10.1007/s12311-017-0907-0.
PubMed 29248983
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Dynamic Visual Acuity in Patients With Bilateral Vestibulopathy: the Impact of Covert-saccades
- ClinicalTrials.gov ID
- NCT02753179
- Acronym / sponsor ID
- COSQOL / 69HCL15_0746
- Conditions
- Vestibular Diseases
- Keywords
- Bilateral vestibular hypofunction, Video Head Impulse Test, Covert-saccades, Quality of life, Dynamic visual acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 27 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bilateral vestibular hypofunction | Experimental | Other: Head Impulse Tests, Other: Dynamic visual acuity Test (DVAT), Other: VEMPs & VEMPo, Other: Dizziness Handicap Inventory, Other: Oscillopsia severity questionnairePatients suffering from chronic bilateral vestibular hypofunction. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria
- Disorder present for over 6 month
- Comprehension of the experiments instructions
- Patient consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head Impulse TestsHead 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 | Bilateral vestibular hypofunction |
| 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 | Bilateral vestibular hypofunction |
| VEMPs & VEMPoVEMPs \& 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 | Bilateral vestibular hypofunction |
| Dizziness Handicap InventoryDizziness 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 | Bilateral vestibular hypofunction |
| Oscillopsia severity questionnaireOscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances. | Other | Bilateral vestibular hypofunction |
Primary outcome
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.
4 secondary outcomes
Quality of life assessed with the Dizziness Handicap Inventory
Time frame: Day 0
Dynamic visual acuity
Time frame: day 0
Oscillopsia severity questionnaire score
Time frame: day 0
Latency of covert-saccades
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Results publication: PubMed 29248983Hermann R, Pelisson D, Dumas O, Urquizar C, Truy E, Tilikete C. Are Covert Saccade Functionally Relevant in Vestibular Hypofunction? Cerebellum. 2018 Jun;17(3):300-307. doi: 10.1007/s12311-017-0907-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caroline TILIKETE, MD principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Head Impulse Tests, Dynamic visual acuity Test (DVAT) and VEMPs & VEMPo in people with Vestibular Diseases, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of covert-saccades (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02753179, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.