Early, Objective Detection of Autism.

NCT06447285 | Not Yet Recruiting DMC

• 1 other identifier: HA-01-R-104
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

1- To test the hypothesis that using the SensoDetect Brainstem Evoked Response Audiometry (BERA) technology may be an effective support tool for pediatricians to detect autism.

Conditions

Autism Spectrum Disorder

Keywords

ABR (Auditory brainstem response)

Outcome Measures

Primary Outcomes (3)

• wave I-VII amplitude

  Wave I-VII amplitude allow comparison of both groups. Group differences between autistic and totally developed (TD) groups will be tested intra-individually and between groups and presented.

  phase 1 of this study one year

• Wave I-VII latencies

  wave I-VII latencies to broaden the perspective and allow a better comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.

  phase 1 of this study one year

• Wave I-VII interpeak intervals

  Wave I-VII interpeak intervals allow a comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.

  phase 1 of this study one year

Study Arms (2)

Autism spectrum disorders group

ACTIVE COMPARATOR

All patients shall be diagnosed according to ADOS15 and DSM-517 criteria by an experienced physician. ADOS is a diagnostic tool considered the "gold standard" in ASD diagnostics.18,19 The children with confirmed diagnoses of autism will be assessed by a senior psychologist using the Stanford-Binet Intelligence Scales - Fifth edition (SB-5)21 to ensure that all ASD patients have an IQ of 70 or above. ASD patients with lower IQ will form a distinct group for specific evaluation. Using sensodetect BERA technology we will in the present study pay attention to wave I-VII amplitude as well as latencies and interpeak intervals to broaden the perspective and allow a better comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.

Diagnostic Test: SensoDetect BERA technology

totally developed group

ACTIVE COMPARATOR

All patients shall be diagnosed according to ADOS15 and DSM-517 criteria by an experienced physician. ADOS is a diagnostic tool considered the "gold standard" in ASD diagnostics.18,19 The children with confirmed diagnoses of autism will be assessed by a senior psychologist using the Stanford-Binet Intelligence Scales - Fifth edition (SB-5)21 to ensure that all ASD patients have an IQ of 70 or above. ASD patients with lower IQ will form a distinct group for specific evaluation. Using sensodetect BERA technology we will in the present study pay attention to wave I-VII amplitude as well as latencies and interpeak intervals to broaden the perspective and allow a better comparison of both groups. Group differences between autistic and TD groups will be tested intra-individually and between groups and presented.

Diagnostic Test: SensoDetect BERA technology

Interventions

SensoDetect BERA technology DIAGNOSTIC_TEST

All recruited participants are to be tested using SensoDetect's patented technology. All tests shall be performed in a quiet and darkened room. Participants will be asked to be comfortably seated in an armchair in a resting position (part 1 only). Surface electrodes will then be attached to the skin over the mastoid bones behind the left and right ear, with a ground electrode on one arm. Two reference electrodes will also be placed on the forehead. Before each test session, the procedure shall be fully explained to the test subject or parents. The subjects will then be instructed to relax with their eyes closed and are permitted to fall asleep (with modifications in part 3). The test will require no active participation other than being subjected to sound stimulation. The subjects will be tested one at a time, and the duration of the testing procedure will be 15 min.

Autism spectrum disorders group; totally developed group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \- All patients attending the clinic of Autism.

You may not qualify if:

• Hearing impairment
• Down syndrome
• Cerebral Palsy
• Significant brain damage Intellectual disability.

Sponsors & Collaborators

• SensoDetect: lead
• Princess Nourah Bint Abdulrahman University: collaborator

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: June 7, 2024
• Study Start: May 29, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share