Perception and Equilibrium After Cochlear Implantation

Deafness Clinical Trial

— ORIENTIMPLANT  

Official title:

Assessment of Perceptual and Postural Performances Following a Cochlear Implantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02723695
• Other study ID #: 2013-A01086-39
• Status: Recruiting
• Phase: N/A
• First received: March 24, 2016
• Last updated: March 24, 2016
• Start date: March 2014
• Est. completion date: March 2019

Study information

• Verified date: March 2016
• Source: Central Hospital, Nancy, France
• Contact: Cécile Parietti-Winkler, MD, PhD
• Phone: +33 383 852 032
• Email: c.parietti[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The cochlear implant is an electrical hearing aid that restores the perception of surrounding sounds and speech intelligibility in profoundly deaf patients. During surgery, the labyrinthine break necessary for insertion into the cochlea of the implantable part may cause a malfunction of the vestibular system which can induce dizziness, balance and perception (of the gravitational vertical) disorders. Vestibular compensation and new sonic interactions could alter the balance control and the visual and postural spatial orientation perceptions.

The usual treatment includes the monitoring of the patient's quality of life, of the vestibular function and of hearing. This study adds an assessment of spatial orientation and of posture.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: March 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Profound deaf patients who are scheduled for a cochlear implantation

• Patients gave their written informed consent

• Patients are affiliated to the french social welfare

Exclusion Criteria:

• Disorders from the motor and/or somesthetic systems (especially the lower limbs)

• Contraindications to the scheduled functional assessments

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Deafness

Intervention

Other:
• Evaluation of postural performances
Postural tests

Locations

Country	Name	City	State
France	University Hospital of Nancy	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in postural perception of the gravitational vertical	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; The measure is the average difference between the gravitational vertical and the tilt of the platform (in degree) over 20 trials.	One year	No
Secondary	Change from baseline in visual perception of the gravitational vertical	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; The measure is the average difference between the gravitational vertical and the tilt of the rod (in degree) over 20 trials.	One year	No
Secondary	Change from baseline in dynamic balance control	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; The composite equilibrium (%) score is calculated over the six conditions of the Sensory Organization Test (Equitest, Neurocom, USA).	One year	No
Secondary	Change from baseline in quiet standing within a specific sound environment	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; The area covered by the centre of pressure in static posturography (eyes open and eyes closed) is calculated during trials within a specific and controled sound environment [quiet - implant OFF, quiet - implant ON, white noise (70 dB) - implant ON, the semantic content (70 dB) - implant OFF]	One year	No
Secondary	Change from baseline in vestibular function	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; Vestibular function is quantified by means of videonystagmography (pendular and caloric tests)	One year	No
Secondary	Change from baseline in speech recognition	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; Speech recognition (in %) is quantified with cochlear phonemic lists of Lafon at 70 dB with and without leep reading.	One year	No
Secondary	Change from baseline in quality of life	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; Score of the quality of life (QoL) questionnaire (WHOQOL-BREF).	One year	No
Secondary	Change from baseline in dizziness	The same assessment will be performed 4 times (3 days before surgery, 3 days, 45 days, and one year after surgery).; Self-rated score of the Dizziness Handicap Inventory (DHI).	One year	No