Recruiting

Observational Study

Sponsor:

Father Flanagan's Boys' Home

Code:

NCT05414903

Conditions

Vestibular Disorder

Hearing Loss, Sensorineural

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Accepted

Interventions

Dynamic Visual Acuity

Reading Outcomes

Static Visual Acuity

Study Details

Brief summary:

Vestibular loss can co-occur with hearing loss causing dual sensory deficits. This project examines vestibular loss as a contributing factor to reading difficulties for children with hearing loss, where previously only the effects of hearing loss and subsequent language difficulties have been considered. These results are expected to influence the identification and habilitation of vestibular loss in children with hearing loss.

Conditions

Vestibular Disorder

Hearing Loss, Sensorineural

Study ID

NCT05414903

Start date

Jun 6, 2022

Status verified date

Dec, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 18

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Children will be required to have nonverbal problem-solving/intelligence scores within 1.5 SD of the mean (mean = 100, SD = 15, 1.5 SD of mean = 77 - 123).
  • Children with normal hearing must have thresholds ≤20 dB HL from 0.25 to 8 kHz.
  • Children with hearing loss must have pure-tone averages > 65 dB HL.

Exclusion Criteria:

  • Fail a vision screen at 20/30
  • Have autism, blindness, or other optic disorders, cerebral palsy, significant neurologic involvement, uncorrectable vision problems, and intellectual disability.
  • Children with nonverbal problem-solving/intelligence scores > 123 or < 77 will be excluded.
  • Each participant's current medications will be reviewed. Children taking medications known to result in oculomotor slowing will be excluded (i.e., anti-depressants, vestibular suppressants, sedatives, etc).

Study Design

Enrollment

90 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Children with Normal Hearing

typically developing children with normal hearing (thresholds ≤ 20 dB HL from 0.25 to 8 kHz) age-matched to the children with hearing loss

active comparator: Children with hearing loss and normal vestibular function

Children with hearing loss will have a pure-tone average (PTA) > 65 dB and normal vestibular evaluation.

experimental: children with hearing loss and vestibular loss

Children with hearing loss will have a pure-tone average (PTA) > 65 dB and and varying degree of vestibular loss (i.e., unilateral or bilateral).

Interventions

Dynamic Visual Acuity

First, participants will report the direction of the open portion of a "Landolt C" (right, left, up, or down) with the head still. Ten targets at 5 acuity levels (LogMAR -0.3, 0, 0.3, 0.7, 1.0, corresponding to Snellen visual acuity of 20/10, 20/20, 20/40, 20/100, 20/200) will be identified. Next, a rate sensor will be placed on the subject's head in the plane of the horizontal canals and htDVA will be measured. The "Landolt C" will be presented automatically when the examiner has moved the subject's head > 150˚/sec. htDVA scores will be the LogMAR at which the subject fails to correctly identify 50% of the visual targets or reaches a LogMAR of -0.3. The overall htDVA score is calculated by subtracting the head still LogMAR from the htDVA LogMAR. htDVA scores will be calculated for right and left head movements separately.

Reading Outcomes

The TOSWRF will be used to assess reading fluency. Children get 3 minutes to identify as many words as possible by drawing boundaries between successive unrelated words.

The TOSCRF will be used to assess reading fluency. Children are allowed 3 minutes to identify as many contextually related words as possible by drawing boundaries between successive words.

The TILLS will be used to assess reading comprehension. Each subject will read a short passage and answer 3 yes/no questions assessing reading comprehension.

A computer based MNREAD Test will be used to assess reading acuity, critical print size and Reading Accessibility Index.

During the TILLS and MNRead test, eye tracking (Eye Link 1000+ eye tracker) will be used to record fixation duration, saccade length, regression frequency, and total time spent.

Static Visual Acuity

The subject's head will be in a headrest. Static visual acuity will be assessed in 9 domains (3 levels of visual target complexity x 3 levels of presentation complexity). The 3 levels of visual target complexity are identifying: 1) colors, 2) the direction of the open prongs of the "Landolt C" (right, left, up, or down), which does not require alphabet knowledge, and 3) single letters (C, D, H, K, O, N, S, R, V, and Z; NIH Toolbox, Li 2014)). The 3 levels of presentation complexity are identifying: 1) 1-visual optotype, 2) a successive row of 5 visual optotypes flashed for 3 seconds (Hillman 1999), and 3) successive rows of optotypes in paragraph form as quickly as possible (i.e., rapid automatized naming). Outcome parameters will be %-correct at each acuity level and reaction time. Fixation duration, saccade length, saccade frequency, regression frequency, and total time spent will be collected via an eye tracker (Eye Link 1000+ eye tracker \[SR Research, EyeLink, Ontario, Canada\]).

Primary outcome measure

  • The Dynamic Visual Acuity Test [ Time Frame: June 6, 2022 - November 30, 2026 ]
  • Reading Ability [ Time Frame: June 6, 2022 - November 30, 2026 ]
  • Static Visual Acuity Test [ Time Frame: June 6, 2022 - November 30, 2026 ]

Central Contacts and Locations

Central contacts

Locations

Boys Town National Research Hospital

Recruiting

Omaha, Nebraska, United States, 68131

Contacts

More Information

Sponsor

Father Flanagan's Boys' Home

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Father Flanagan's Boys' Home on 2025-12-23.