## Protocol Section
### Identification Module
**NCT ID:** NCT02753179

**Acronym:** COSQOL

**Brief Title:** Covert-saccades, Dynamic Visual Acuity and Quality of Life

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

#### Organization Study ID Info
**ID:** 69HCL15_0746
#### Organization
**Class:** OTHER
**Full Name:** Hospices Civils de Lyon
### Status Module
#### Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-01-16

**Type:** ESTIMATED

**Last Update Submit Date:** 2017-01-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-01

**Type:** ACTUAL

#### Start Date
**Date:** 2016-05

**Status Verified Date:** 2017-01

#### Study First Post Date
**Date:** 2016-04-27
**Type:** ESTIMATED
**Study First Submit Date:** 2016-04-25
**Study First Submit QC Date:** 2016-04-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hospices Civils de Lyon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Vestibular Diseases

**Keywords:**

- Bilateral vestibular hypofunction

- Video Head Impulse Test

- Covert-saccades

- Quality of life

- Dynamic visual acuity

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** BASIC_SCIENCE

#### Enrollment Info

**Count:** 20

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients suffering from chronic bilateral vestibular hypofunction.

**Intervention Names:**

- Other: Head Impulse Tests

- Other: Dynamic visual acuity Test (DVAT)

- Other: VEMPs & VEMPo

- Other: Dizziness Handicap Inventory

- Other: Oscillopsia severity questionnaire

**Label:** Bilateral vestibular hypofunction

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bilateral vestibular hypofunction

**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.

**Name:** Head Impulse Tests

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Bilateral vestibular hypofunction

**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.

**Name:** Dynamic visual acuity Test (DVAT)

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Bilateral vestibular hypofunction

**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.

**Name:** VEMPs & VEMPo

**Type:** OTHER

#### Intervention 4

**Arm Group Labels:**

- Bilateral vestibular hypofunction

**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

**Name:** Dizziness Handicap Inventory

**Type:** OTHER

#### Intervention 5

**Arm Group Labels:**

- Bilateral vestibular hypofunction

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

**Name:** Oscillopsia severity questionnaire

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Frequency of covert-saccades

**Time Frame:** Day 0

#### Secondary Outcomes

**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

**Measure:** Quality of life assessed with the Dizziness Handicap Inventory

**Time Frame:** Day 0

**Description:** Dynamic visual acuity is a measure of threshold for binocular reading of letters that are presented on a screen during head impulse test

**Measure:** Dynamic visual acuity

**Time Frame:** day 0

**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

**Measure:** Oscillopsia severity questionnaire score

**Time Frame:** day 0

**Description:** Latency of covert saccades correspond to the time between the beginning of head impulse and the initiation of the first covert-saccade

**Measure:** Latency of covert-saccades

**Time Frame:** Day 0

### Eligibility Module

**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

**Maximum Age:** 90 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Bron

**Country:** France

**Facility:** Unité de Neuro-Ophtalmologie Hôpital Neurologique

**Zip:** 69500

#### Overall Officials

**Official 1:**

**Affiliation:** Institut National de la Santé Et de la Recherche Médicale, France

**Name:** Caroline TILIKETE, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007759

- Term: Labyrinth Diseases

- ID: D000004427

- Term: Ear Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M18387

- Name: Vestibular Diseases

- Relevance: HIGH

- As Found: Vestibular Diseases

- ID: M850

- Name: Bilateral Vestibulopathy

- Relevance: LOW

- As Found: Unknown

- ID: M10779

- Name: Labyrinth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10782

- Name: Labyrinthitis

- Relevance: LOW

- As Found: Unknown

- ID: M7601

- Name: Ear Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: HIGH

- As Found: Quality of Life

### Condition Browse Module - Meshes

- ID: D000015837

- Term: Vestibular Diseases

### Misc Info Module

- Version Holder: 2024-05-24
