NCT06586788 (EAER21) is a NA clinical trial of Eyelink Portable Duo in Autism, sponsored by Indiana University.

Who is sponsoring NCT06586788?

NCT06586788 is sponsored by Indiana University.

What drugs are being tested in NCT06586788?

Interventions in NCT06586788: Eyelink Portable Duo, Integrated PCP Diagnosis and Eye-tracking Biomarker.

Is NCT06586788 still recruiting?

NCT06586788 is currently completed. Last updated 31 October 2024.

Are results published for NCT06586788?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-10-31 · How we verify

NCT06586788: EAER21

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Validation of Indiana's Early Evaluation Hub System

Completed NA Results posted Last updated 31 October 2024

What this trial tests

NA trial testing Eyelink Portable Duo in Autism in 154 participants. Completed in 23 September 2022.

Timeline

7 June 2019

Primary endpoint
23 September 2022

23 September 2022

Quick facts

Lead sponsor	Indiana University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	154
Start date	7 June 2019
Primary completion	23 September 2022
Estimated completion	23 September 2022
Sites	7 locations across United States

Drugs / interventions tested

Eyelink Portable Duo
Integrated PCP Diagnosis and Eye-tracking Biomarker

Conditions studied

Autism — all drugs for Autism →

Sponsor

Indiana University

Who can join

Adults 14 Months to 48 Months, any sex, with Autism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Agreement Between Composite Eye-tracking Biomarker and Expert Autism-specialist Primary · Day 1

Sensitivity and specificity of a composite eye-tracking (i.e., index) test, which was a consolidated measure based on significant eye-tracking indices, compared to reference standard expert clinical autism diagnosis.

Group	Value	95% CI
Autism (Reference Standard)	79
Non-Autism (Reference Standard)	10
Autism (Reference Standard)	23
Non-Autism (Reference Standard)	34

Agreement Between Integrated PCP, Eye-tracking Biomarker Score and Expert Autism-specialist Primary · Day 1

Classification and Regression Tree (CART) analysis, based on recursive partitioning, is used to determine which combination of variables (EE Hub PCP diagnosis, diagnostic certainty, composite biomarker, and biomarker frequency \[sum of all individual biomarkers (0-6) that exceeded the 95% specificity threshold for each child\]) best predicted reference standard autism diagnosis.

Group	Value	95% CI
Autism (Reference Standard)	88
Non-Autism (Reference Standard)	4
Autism (Reference Standard)	9
Non-Autism (Reference Standard)	26

Sponsor's own description

The investigators' objective is to test an innovative method of autism diagnosis that integrates clinical evaluation and assessment of biobehavioral markers in a large high-risk community-referral sample of children in the primary care setting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Eyelink Portable Duo

Trials testing the same drug.

NCT06703125 — The Alama Project: Autism Outcomes and Neurobehavioral Markers in Young Children Born to Mothers With HIV in Kenya · NA · recruiting
NCT06471504 — Use of Eye Tracking to Aid in Autism Risk Detection · NA · recruiting
NCT06685822 — Expanding Autism Diagnostic Biomarkers to Kenya · NA · completed

Other recruiting trials for Autism

Currently open trials in the same condition.

NCT07367256 — Using Virtual Reality to Improve Emotion Understanding in Children With Autism · NA · recruiting
NCT06853665 — The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine · Phase 4 · recruiting
NCT06523387 — Online Pivotal Response Treatment Training in Autism Spectrum Disorder · NA · recruiting
NCT07304440 — Adia MED of Winter Park LLC Autism Spectrum Disorder Research Study · Phase 1, PHASE2 · recruiting
NCT07403396 — Static Balance Assessment in Children With ASD Using VRRS · recruiting

Other Indiana University trials

Trials by the same sponsor.

NCT07470086 — The Role of Environmental Temperatures in Respiratory Control · NA · not yet recruiting
NCT07470099 — The Role of Breathing Perception in Respiratory Control · NA · not yet recruiting
NCT07179952 — Efficacy and Safety of Slow Release Dehydroepiandrosterone (DHEA ) · Phase 2 · not yet recruiting
NCT07070804 — Maternal Biomarkers and Environmental Contributors to Autism Spectrum Disorders in Children of First-time Mothers · not yet recruiting
NCT07499583 — Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder · Phase 1, PHASE2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06586788 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Indiana University
Last refreshed: 31 October 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06586788.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing