Gødstrup Regional Hospital
Herning, 7400, Denmark
Location status: Recruiting
NCT Number: NCT06229730
The goal of this age-based cohort study is to provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics. The participants will be children in the age of 6 months to 10 years, without any known hearing or balance problems. The test protocol consists of questionnaires, hearing screening and vestibular and postural assessments.
Interested in participating?
Request Info6 month–10 year
All sexes
Observational
Herning, 7400, Denmark
Location status: Recruiting
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.
Knowledge about the prevalence of vestibular impairment and normative data of vestibular function in the Danish pediatric population is missing.
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 provide normative data of vestibular function in the general Danish pediatric population. Thus, the investigators will be able to compare patient data with norms, allowing for more precise diagnostics.
Methods: The study is an age-based cohort study. Participants are children in the age of 6 months to 10 years, without any known hearing or balance problems. The participants are recruited in local nurseries, kinder gardens, and schools. All participants will go through a test protocol consisting of questionnaires, hearing screening and vestibular and postural assessments.
The primary endpoints are age-based norms for v-HIT, c and oVEMP, and posturographic results. The secondary endpoints are number of subjects with successful results of the vestibular test protocol 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
For v-HIT, the Synapsys v-HIT Ulmer device is used.
Other names: vHIT
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.
Other names: cVEMP
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.
Other names: oVEMP
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.
Other names: CDP
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.
Other names: DHI-PC
Time frame: Measured at baseline.
Outcome measures: Age-based norms for mean VOR gain
Time frame: Measured at baseline.
Outcome measures: Age-based norms for VOR gain asymmetry in percent (%).
Time frame: Measured at baseline.
Outcome measures: Description of saccades (overt and covert saccades)
Time frame: Measured at baseline.
Outcome measures: Age-based norms for latency P1 and latency N1 in milliseconds (ms)
Time frame: Measured at baseline.
Outcome measures: Age-based norms for rectified interpeak amplitude P1-N1
Time frame: Measured at baseline.
Outcome measures: Age-based norms for averaged EMG in µV
Time frame: Measured at baseline.
Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)
Time frame: Measured at baseline.
Outcome measures: Age-based norms for latency N1 and latency P1 in milliseconds
Time frame: Measured at baseline.
Outcome measures: Age-based norms for interpeak amplitude N1-P1 in µV
Time frame: Measured at baseline.
Outcome measures: Age-based norms for left-right asymmetry ratio in percent (%)
Time frame: Measured at baseline.
Outcome measures: Aged-based norms for Sensory Organization Test (SOT):
Time frame: Measured at baseline.
Outcome measures: Aged-based norms for motor control test (MCT):
Time frame: Measured at baseline.
Outcome measures: Aged-based norms for adaptation test (ADT):
Time frame: 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.
Time frame: Measured at baseline
Number of subjects with successful results of each of the vestibular assessments.
Contact information is provided by the study sponsor or research team.
Gødstrup Hospital
Other
Vestibular ASsessment In Children - Balance Function in Normal Children and Specific Risk Groups (VASIC)
Acronym: VASIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06229717
Children, Only, Dizziness
Herning, Denmark
View Trial DetailsNCT06229704
Children, Only, Communication Disorders
Herning, Denmark
View Trial DetailsNCT07648511
Children, Only, Hemiparesis
Damietta, Egypt
View Trial DetailsNCT07576491
Children, Only, Constipation
Lahore, Punjab Province, Pakistan
View Trial Details