Clinical trial NCT06447285: Early, Objective Detection of Autism.
Official title: Early, Objective Detection of Autism.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ABR (Auditory brainstem response)
Lead sponsor: SensoDetect
Sponsor class: INDUSTRY
Collaborators: name: Princess Nourah Bint Abdulrahman University
First posted: 2024-06-07
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SCREENING

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.

Detailed description: This study will be conducted through two phases:

Phase I: A case-control study.

This will be done at Princess Noura University/ King Abdullah Abdulaziz University Hospital, Riyadh, Kingdom of Saudi Arabia from January 2024 to January 2027.

The SensoDetect BERA technology previously described8,9,13,14 will be used in all parts of the study in the following way:

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 comfortably sit 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 sound stimulation. The subjects will be tested one at a time, and the duration of the testing procedure will be 15 min.

The method is based on an electrophysiological test battery that emits 1024 click sounds divided into 4 sessions for 14 minutes. The data analysis software uses advanced mathematical algorithms and Artificial intelligence (AI) to analyze and distinguish the patient's markers and compare them with diagnostic and non-diagnostic groups. BERA is CE and MDD (MDD stands for Medical Device Directive and is an approval for the device to be used under European law) approved. SensoDetect holds the ISO standard under medical technical products 13485:2016. After the test is completed, the result will be sent for analysis using SensoDetect's analytical software (SensoLytics). The AI classification model used for analyzing traits and predicting diagnosis is Gaussian Naïve Bayes.

Eligibility criteria: Phase I:

Inclusion Criteria:

- All patients attending the clinic of Autism.

Exclusion Criteria:

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

Primary outcomes:
measure: wave I-VII amplitude
timeFrame: phase 1 of this study one year
measure: Wave I-VII latencies
timeFrame: phase 1 of this study one year
measure: Wave I-VII interpeak intervals
timeFrame: phase 1 of this study one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: