NCT04504890

Brief Summary

This study intends to establish a relationship between oculovestibular eye tracking measures, measures of ADHD, and medication prescribed for ADHD.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2020

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

1.1 years

First QC Date

August 5, 2020

Last Update Submit

October 22, 2020

Conditions

ADHD - Combined TypeADHDADHD Predominantly Inattentive TypeADHD, Predominantly Hyperactive - Impulsive

Keywords

ADHDEYE-SYNCeye trackingoculomotorvestibular

Outcome Measures

Primary Outcomes (3)

  • Eye Tracking and ADHD measure correlation

    Zero-order correlations among eye tracking parameters, CAARS ADHD indices, CBRS ADHD indices, and confounding variables

    through study completion, an average of 1 year

  • Eye Tracking ADHD Diagnostic ROC

    Specific eye tracking parameters will be compared to determine which have the greatest diagnostic utility. Supervised machine learning models will be generated and optimized ROC AUC for both children and adults using eye tracking parameters as input and CAARS indices, CBRS indices, and clinical diagnosis as outcomes

    through study completion, an average of 1 year

  • MANCOVA Eye Tracking in ADHD Treatment Population

    Repeated measures multivariate analysis of covariance (MANCOVA) will be used to compare eye tracking performance over time in adults and children with ADHD (medicated and unmedicated)

    through study completion, an average of 1 year

Study Arms (4)

Adults - Diagnosis

Adults seeking treatment for an attention-related disorder

Device: EYE-SYNC

Adults - Prescribed

Adults who have been diagnosed with ADHD and prescribed medication treatment for the disorder

Device: EYE-SYNC

Children - Diagnosis

Children seeking treatment for an attention-related disorder

Device: EYE-SYNC

Children - Prescribed

Children who have been diagnosed with ADHD and prescribed medication treatment for the disorder

Device: EYE-SYNC

Interventions

EYE-SYNCDEVICE

Nystagmograph used to measure eye movement

Adults - DiagnosisAdults - PrescribedChildren - DiagnosisChildren - Prescribed

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Children and adults seeking diagnosis and/or treatment for attention-related disorder.

You may qualify if:

  • Men and women ages 6-70 seeking evaluation and treatment for ADHD.

You may not qualify if:

  • Clinical diagnosis of a neurological condition including the following: stroke, multiple sclerosis, epilepsy, brain tumor/cancer, dyslexia, nystagmus and/or other major neurological condition.
  • Clinical diagnosis of any of the following eye-sight abnormalities: uncorrected amblyopia, uncorrected myopia, uncorrected presbyopia, uncorrected farsightedness or uncorrected Astigmatism.
  • Psychiatric history with any of the following:
  • LIFETIME: Clinical diagnosis of a psychotic disorder; bipolar disorder
  • LAST YEAR: Clinical diagnosis of major depressive disorder; PTSD; clinical diagnosis of substance abuse disorder; major anxiety disorder
  • Use of a psychotropic medication
  • Impairment of cranial nerves II-VI
  • Participants who receive a 'Poor' or 'Fair' eye tracking quality result on either their baseline or follow-up evaluations will be excluded from analysis. Subjects may not repeat participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Palo Alto Medical Foundation - San Carlos Center

San Carlos, California, 94070, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Benjamin Cheyette, M.D.,Ph.D.

CONTACT

650.278.1814cheyetbr@sutterhealth.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2020

First Posted

August 7, 2020

Study Start

July 16, 2020

Primary Completion

August 5, 2021

Study Completion

October 5, 2021

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)