Trial Outcomes & Findings for Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses (NCT NCT03971578)
NCT ID: NCT03971578
Last Updated: 2023-08-14
Results Overview
Auditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans.
Recruitment status
COMPLETED
Target enrollment
81 participants
Primary outcome timeframe
One Week
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
Autism Spectrum Disorders Group
Children identified as having Autism Spectrum Disorder Age: 2.5 to 7 years old
No Intervention Provided: No Intervention Provided
|
Normal Control Group
Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 2.5 to 7 years old
No Intervention Provided: No Intervention Provided
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
56
|
|
Overall Study
COMPLETED
|
14
|
37
|
|
Overall Study
NOT COMPLETED
|
11
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Screening for Autism Spectrum Disorders Using Auditory Brainstem Responses
Baseline characteristics by cohort
| Measure |
Autism Spectrum Disorders Group
n=25 Participants
Children identified as having Autism Spectrum Disorder Age: 3.5 to 4.5 years old
No Intervention Provided: No Intervention Provided
|
Normal Control Group
n=56 Participants
Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 3.5 to 4.5 years old
No Intervention Provided: No Intervention Provided
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
53.0 months
STANDARD_DEVIATION 14.2 • n=5 Participants
|
47.3 months
STANDARD_DEVIATION 17.1 • n=7 Participants
|
49.1 months
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
56 participants
n=7 Participants
|
81 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One WeekAuditory Brainstem Response (ABR) peak V latency measurement for the five stimulation rates used in the study. The latency is the time, measured in ms, from the onset of the stimulus to the generation of the response peak component. ABR peak V is the most prominent response peak component in humans.
Outcome measures
| Measure |
Autism Spectrum Disorders Group
n=14 Participants
Children identified as having Autism Spectrum Disorder Age: 2.5 to 7 years old
No Intervention Provided: No Intervention Provided
|
Normal Control Group
n=37 Participants
Normal children without Autism Spectrum Disorder or other identified developmental disability Age: 2.5 to 7 years old
No Intervention Provided: No Intervention Provided
|
|---|---|---|
|
ABR Peak V Latency
Peak V Latency at 19.3 Hz Rate
|
6 ms
Standard Deviation 0.27
|
5.8 ms
Standard Deviation 0.16
|
|
ABR Peak V Latency
Peak V Latency at 39.3 Hz Rate
|
6.29 ms
Standard Deviation 0.36
|
5.99 ms
Standard Deviation 0.16
|
|
ABR Peak V Latency
Peak V Latency at 58.59 Hz Rate
|
6.48 ms
Standard Deviation 0.25
|
6.26 ms
Standard Deviation 0.21
|
|
ABR Peak V Latency
Peak V Latency at 195.31 Hz Rate
|
7.07 ms
Standard Deviation 0.31
|
6.89 ms
Standard Deviation 0.25
|
|
ABR Peak V Latency
Peak V Latency at 234.38 Hz Rate
|
7.45 ms
Standard Deviation 0.58
|
7.28 ms
Standard Deviation 0.32
|
Adverse Events
Autism Spectrum Disorders Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Normal Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Rafael E. Delgado, Director of Research & Development
Intelligent Hearing Systems
Phone: 305-668-6102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place