Early, Objective Detection of Autism.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SensoDetect BERA technology.
- Who it may be relevant to
- Registry conditions: Autism Spectrum Disorder. Basic parameters: 3 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Diagnostic test SensoDetect BERA technology
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 b
Primary outcome measures
- wave I-VII amplitude [Time frame: phase 1 of this study one year]
- Wave I-VII latencies [Time frame: phase 1 of this study one year]
- Wave I-VII interpeak intervals [Time frame: phase 1 of this study one year]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06447285 · HA-01-R-104