Vestibular and Postural Function in an Unselected Group of Children With Sensorineural Hearing Loss

Not yet recruiting

• Conditions: Sensorineural Hearing Loss; Children, Only; Vestibular Function; Vestibular Disorder
• Interventions: Diagnostic Test: video Head Impulse Test; Diagnostic Test: Cervical Vestibular Evoked Myogenic Potential; Diagnostic Test: Ocular Vestibular Evoked Myogenic Potential; Diagnostic Test: Computerized Dynamic Posturography; Other: Dizziness Handicap Inventory for patient caregivers

• Registration Number: NCT06229717
• Lead Sponsor: Gødstrup Hospital

Brief Summary

The goal of this prospective cohort study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss. The main hypothesis of the study is that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss. The participants will be children in the age of 3-10 years with sensorineural hearing loss. The test protocol consists of questionnaires and vestibular and postural assessments.

Detailed Description

Balance problems in children are an overlooked issue in the Danish healthcare system. Dysfunction of the vestibular system, i.e. vestibular dysfunction (VD), can have significant consequences for children's development and quality of life.

In particular, children with sensorineural hearing loss are at risk of developing VD. Hence, VD has been reported in 14 % to 91 % of children with sensorineural hearing loss. The close anatomical and embryological relationship between the hearing system and the vestibular system may of course explain this correlation.

The investigators aim for a child friendly and reliable vestibular test protocol in the study. According to the investigators studies as well as international reports, the investigators have chosen a vestibular test protocol with Video Head Impulse Test (v-HIT), cervical and ocular Vestibular Evoked Myogenic Potential (c and oVEMP) as the tests are feasible, valid, and child friendly. To evaluate overall balance ability, the children are tested on a Computerized Dynamic Posturography.

The aim of the study is to investigate the vestibular function in children with unilateral or bilateral sensorineural hearing loss.

Hypothesis: The investigators expect that abnormal vestibular test results will be found in 20-30 % of the children with sensorineural hearing loss.

Methods: The study is a prospective cohort study. Participants are a prospective, unselected group of children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss. The participants are recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark.

All participants will go through a test protocol consisting of questionnaires and vestibular and postural assessments.

The primary endpoints are results of v-HIT, c and oVEMP, and posturography, which are compared to normative values. The secondary endpoints are prevalence of vestibular dysfunction and mean total Dizziness Handicap Inventory for patient caregivers (DHI-PC) score. A number of variables are collected such as demographics, developmental milestones, family history with focus on hearing and balance.

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-18
• Last Update Submitted: 2024-01-18
• Study First Posted: 2024-01-29
• Last Update Posted: 2024-01-29
• Study Start: 2025-08
• Primary Completion: 2027-08
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Children in the age of 3-10 years
• Uni- or bilateral sensorineural hearing loss > 20 dB bone conduction pure tone average measured at frequencies 0.5, 1, 2, 4 kHz
• Written informed consent from the parents.

Exclusion Criteria

• Previous inner ear surgery
• Visual impairment to such a degree that the child is not able to maintain fixation on a dot one meter away.
• Congenital nystagmus
• Compromised eye muscle mobility
• VEMP-electrode allergy
• History of symptomatic head or neck trauma
• Prescription of medicine which alters vestibular outputs (for instance sedative antihistamines)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with sensorineural hearing loss	video Head Impulse Test	Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
Children with sensorineural hearing loss	Computerized Dynamic Posturography	Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
Children with sensorineural hearing loss	Cervical Vestibular Evoked Myogenic Potential	Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
Children with sensorineural hearing loss	Dizziness Handicap Inventory for patient caregivers	Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark
Children with sensorineural hearing loss	Ocular Vestibular Evoked Myogenic Potential	Children in the age of 3-10 years with either unilateral or bilateral sensorineural hearing loss is recruited at The Audiologic Clinic at Viborg Regional Hospital, Denmark

Primary Outcome Measures

Name	Time	Method
video Head Impulse Test (vHIT)	Measured at baseline.	Outcome measures: description of saccades (overt and covert saccades)
Cervical Vestibular Evoked Myogenic Potential (cVEMP):	Measured at baseline.	Outcome measures: left-right asymmetry ratio in percent (%)
Computerized Dynamic Posturography (CDP)	Measured at baseline.	Outcome measures: ADaptation Test (ADT): • Mean sway energy score of toes-up and toes-down respectively. The sway energy score quantifies the force magnitude required to overcome the postural instability.
Ocular Vestibular Evoked Myogenic Potential (oVEMP):	Measured at baseline.	Outcome measures: left-right asymmetry ratio in percent (%)

Secondary Outcome Measures

Name	Time	Method
Vestibular dysfunction	Measures at baseline	Prevalence of vestibular dysfunction
Dizziness Handicap Inventory for patient caregivers (DHI-PC):	Measured at baseline.	Outcome measures: Mean total DHI-PC score. DHI-PC is a caregiver-reported 21-item questionnaire. For each question there are three possible answers: yes, sometimes or no. Each answer provides respectively 4, 2 and 0 points. The total DHI scores range from 0 to 84 with higher score being consistent with more limitation and more severe handicap.