Reading Outcomes in Children With Vestibular Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorFather Flanagan's Boys' Home
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Dynamic Visual Acuity
BehavioralFirst, 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
BehavioralThe 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
BehavioralThe 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 \[SR Research, EyeLink, Ontario, Canada\]).
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Children with Normal HearingActive comparator 3 interventions
Group B: Children with hearing loss and normal vestibular functionActive comparator 3 interventions
Group C: children with hearing loss and vestibular lossExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
The Dynamic Visual Acuity Test
The dynamic visual acuity test measures the ability to see clearly during head movement. 3 type of head movement will be assessed: Active (participant moves their own head), Passive (Investigator moves participant's head) and impulse (Investigator moves participant's head).
Time frame
June 6, 2022 - November 30, 20262
Reading Ability
The Test of Silent Word Reading Fluency, 2nd Ed (TOSWRF) The Test of Silent Contextual Reading Fluency, 2nd Ed (TOSCRF) The Test of Integrated Language and Literacy Skills (TILLS): Reading Comprehension subtest MNREAD Test
Time frame
June 6, 2022 - November 30, 20263
Static Visual Acuity Test
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
Time frame
June 6, 2022 - November 30, 2026Sponsors and contacts
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Source ClinicalTrials.gov