Reading Outcomes in Children With Vestibular Loss

Part of paid clinical trials in Omaha, Nebraska.

Sponsor
Father Flanagan's Boys' Home
Study ID
NCT05414903
Status
Recruiting
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Conditions

  • Hearing Loss, Sensorineural
  • Vestibular Disorder

Eligibility Criteria

Sex
ALL
Age
7 Years - 18 Years
Healthy Volunteers
Accepted

Interventions

  • Dynamic Visual Acuity — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 \[SR Research, EyeLink, Ontario, Canada\]).

Study Details

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.

Key Dates

Start date
Jun 6, 2022
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boys Town National Research HospitalOmahaNebraska68131
Kristen L Janky, PhD
[email protected]
15313556535

Find similar trials in Omaha, NE

By research site
Boys Town National Research Hospital· Omaha, NE

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