Clinical trial NCT04363580: Creation of Auditory Processing Disorder Screening Tool in French
Official title: Creation of Auditory Processing Disorder Screening Tool in French
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Auditory Processing Disorder
Keywords: Auditory processing disorder
Screening tool
Children
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-04-27
Enrollment: 16
Sex: ALL
Minimum age (years): 7
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children referred for an assessment of central auditory skills at ENT unit of Necker hospital.

Brief summary: The objective of the study is to validate a screening tool for auditory processing disorder in children of 7 to 13 years old. This screening tool was created based on literature and combines a questionnaire and a mini-battery of tests composed of verbal and nonverbal assessments.

Detailed description: Hearing plays a vital role in the development of a child. Hearing is based on two main systems: the peripheral system and the central system. Peripheral hearing, which includes the outer, middle, and inner ear and the auditory nerve, can detect sound signals.

For its part, the central system, which is composed of auditory structures from the auditory nerve to the brain, makes it possible to process these sound signals and to analyze them. Peripheral hearing damage will result in deafness while a problem in the central auditory system will be called auditory processing disorder. Peripheral deafness can be detected from birth through neonatal screening for deafness. The symptoms of an auditory processing disorder can easily be confused with those caused by attention deficit disorder with or without hyperactivity and a specific language disorder. Auditory processing disorder is often unknown in the medical and educational worlds, and children are referred late for consultation. In addition, the lack of French screening tests for auditory processing disorder and the long waiting lists for specialized consultations help to delay diagnosis and hinder early intervention. Auditory processing disorder affects about 2 to 3% of school-aged children.

The objective of the study is to validate a screening tool for auditory processing disorder in children of 7 to 13 years old. This screening tool was created based on literature and combines a questionnaire and a mini-battery of tests composed of verbal and nonverbal assessments.

Eligibility criteria: Inclusion Criteria:

* Child aged 7 to 13 on the day of enrollment.
* Child referred for assessment of central auditory skills, who did not have an auditory processing disorder -type assessment before.
* Hearing thresholds at both ears between 0 decibels Hearing Level (dB HL) and 15 dB HL at 250, 500, 1000, 2000, 4000 and 8000 Hz. Absence of auditory neuropathy.
* Child affiliated to a social security scheme.
* Holders of parental authority who do not oppose the patient's participation in research.

Exclusion Criteria:

* Known neurological disorder (epilepsy, cranial trauma, etc.).
* Non medicated attention deficit since the presence of such a deficit can affect the child's performance during the auditory processing disorder assessment.
* Intellectual disability since impairment of cognitive skills may also explain poor test performance (IQ \<80).

Primary outcomes:
measure: Sensitivity
timeFrame: 2 years
measure: Specificity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Natalie Loundon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Isabelle Rouillon, MD
role: STUDY_DIRECTOR
References: