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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with sensorineural hearing loss | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| video Head Impulse Test | Diagnostic Test | For v-HIT, the Synapsys v-HIT Ulmer device is used. |
|
| Measure | Description | Time Frame |
|---|---|---|
| video Head Impulse Test (vHIT) | Outcome measures: mean VOR gain | Measured at baseline. |
| video Head Impulse Test (vHIT) | Outcome measures: VOR gain asymmetry in percent (%) | Measured at baseline. |
| video Head Impulse Test (vHIT) | Outcome measures: description of saccades (overt and covert saccades) | Measured at baseline. |
| Cervical Vestibular Evoked Myogenic Potential (cVEMP): | Outcome measures: latency P1 and latency N1 in milliseconds (ms) | Measured at baseline. |
| Cervical Vestibular Evoked Myogenic Potential (cVEMP): | Outcome measures: rectified interpeak amplitude P1-N1 | Measured at baseline. |
| Cervical Vestibular Evoked Myogenic Potential (cVEMP): | Outcome measures: averaged EMG in μV | Measured at baseline. |
| Cervical Vestibular Evoked Myogenic Potential (cVEMP): | Outcome measures: left-right asymmetry ratio in percent (%) | Measured at baseline. |
| Ocular Vestibular Evoked Myogenic Potential (oVEMP): | Outcome measures: latency N1 and latency P1 in milliseconds |
| Measure | Description | Time Frame |
|---|---|---|
| Vestibular dysfunction | Prevalence of vestibular dysfunction | Measures at baseline |
| Dizziness Handicap Inventory for patient caregivers (DHI-PC): | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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A prospective, unselected group of 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. We intend to include all consecutive children fitting the inclusion and exclusion criteria.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Signe F Bønløkke, PhD student | Contact | +45 41405064 | siband@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Therese Ovesen, Professor | University Clinic for Balance, Flavour and Sleep, Department of ENT, Gødstrup Hospital, DK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gødstrup Regional Hospital | Recruiting | Herning | 7400 | Denmark |
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| Cervical Vestibular Evoked Myogenic Potential | Diagnostic Test | For cVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate. |
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| Ocular Vestibular Evoked Myogenic Potential | Diagnostic Test | For oVEMP, the Eclipse (Interacoustic, Middelfart, Denmark) is used. To bypass the frequent middle ear problems bone conduction stimuli (B-81, Interacoustic, Middelfart, Denmark) are administrated. The bone conductor is placed on the mastoid process and two trials at 70 dB nHL are conducted to check waveform reproducibility. 500 Hz short tone bursts (2-2-2 ms) are applied at 5 per second stimulus repetition rate. |
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| Computerized Dynamic Posturography | Diagnostic Test | To evaluate functional balance of the children and the relative contributions of the vision, proprioception, and vestibular system a CDP from Virtualis (Virtualis, Montpellier, France) is used. |
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| Dizziness Handicap Inventory for patient caregivers | Other | DHI is a caregiver-reported 21- item questionnaire. It is designed to evaluate the perceived quality of life and handicap resulting from dizziness and unsteadiness for the pediatric population. 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. Scores under 16 are characterized as no limitation or handicap. A score from 16-26 present a mild perceived handicap and mild limitations. A DHI-score between 26-43 is classified as a moderate problem, and a score above 43 describes a severe perceived handicap and severe limitations. |
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| Measured at baseline. |
| Ocular Vestibular Evoked Myogenic Potential (oVEMP): | Outcome measures: interpeak amplitude N1-P1 in μV | Measured at baseline. |
| Ocular Vestibular Evoked Myogenic Potential (oVEMP): | Outcome measures: left-right asymmetry ratio in percent (%) | Measured at baseline. |
| Computerized Dynamic Posturography (CDP) | Outcome measures: Sensory Organization Test (SOT):
| Measured at baseline. |
| Computerized Dynamic Posturography (CDP) | Outcome measures: Motor Control Test (MCT): • Mean latency of the medium and the big movement respectively in anterior and posterior direction measured in milliseconds. | Measured at baseline. |
| Computerized Dynamic Posturography (CDP) | 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. | Measured at baseline. |
| Measured at baseline. |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D004244 | Dizziness |
| ID | Term |
|---|---|
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D058585 | Vestibular Evoked Myogenic Potentials |
| ID | Term |
|---|---|
| D019054 | Evoked Potentials, Motor |
| D005071 | Evoked Potentials |
| D000071080 | Cortical Excitability |
| D055724 | Electrophysiological Phenomena |
| D010829 | Physiological Phenomena |
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