NCT04363580

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

September 18, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2021

Completed
Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

April 23, 2020

Last Update Submit

March 10, 2026

Conditions

Keywords

Auditory processing disorderScreening toolChildren

Outcome Measures

Primary Outcomes (2)

  • Sensitivity

    Comparison of the results of the auditory processing disorder screening tool with those obtained at the auditory processing disorder reference diagnostic battery. Sensitivity: Number of true positives / Number of true positives + Number of false negatives For the screening tool questionnaire, a score of 1 is given for each item for which parents or teachers believe that the child has a problem. A score of more than 50% on the questionnaire (or sub-section) suggests that the child is at risk of having an auditory processing disorder. The child would also be at risk when he fails at least one hearing test of the tool.

    2 years

  • Specificity

    Comparison of the results of the auditory processing disorder screening tool with those obtained at the auditory processing disorder reference diagnostic battery. Specificity: Number of true negatives / Number of true negatives + Number of false positives For the screening tool questionnaire, a score of 1 is given for each item for which parents or teachers believe that the child has a problem. A score of more than 50% on the questionnaire (or sub-section) suggests that the child is at risk of having an auditory processing disorder. The child would also be at risk when he fails at least one hearing test of the tool.

    2 years

Study Arms (1)

Patients

Children consulting for an assessment of central auditory skills

Other: Auditory processing disorder screening tool

Interventions

Screening tool : a questionnaire completed by the parents and the child's teacher and a mini-battery of tests composed of verbal and nonverbal assessments. Questions for parents are grouped into four sections: * Reference pattern and portrait of the child. * Auditory history. * History of speech and language development. * School history. The teacher questionnaire has seven sections: * Portrait of the child. * Reading and writing. * Speaking. * Mathematics. * Music. * Memory. * Listening skills and understanding: * Concentration and organization. * Environment. Mini-battery of tests: * Dichotic Numeric Listening Test. * Identification test of 15 patterns of frequency-varying sounds at each ear. * Test of 10 monosyllables in noise per ear. * Auditory memory test by measuring the range of figures (instead of words in order to reduce the contribution of language processing).

Patients

Eligibility Criteria

Age7 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children referred for an assessment of central auditory skills at ENT unit of Necker hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

MeSH Terms

Conditions

Auditory Perceptual Disorders

Condition Hierarchy (Ancestors)

Auditory Diseases, CentralRetrocochlear DiseasesEar DiseasesOtorhinolaryngologic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Natalie Loundon, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR
  • Isabelle Rouillon, MD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

September 18, 2020

Primary Completion

May 15, 2021

Study Completion

May 15, 2021

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations