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Early, Objective Detection of Autism.
Sponsor: SensoDetect
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.
Key Details
Gender
All
Age Range
3 Years - 8 Years
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2024-05-29
Completion Date
2027-10-01
Last Updated
2024-06-07
Healthy Volunteers
Yes
Conditions
Interventions
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 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.