- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05414903
Reading Outcomes in Children With Vestibular Loss
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kristen L Janky, PhD
- Phone Number: 15313556535
- Email: kristen.janky@boystown.org
Study Contact Backup
- Name: Jessie N Patterson, PhD
- Phone Number: 15313556333
- Email: jessie.patterson@boystown.org
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68131
- Recruiting
- Boys Town National Research Hospital
-
Contact:
- Kristen L Janky, PhD
- Phone Number: 15313556535
- Email: kristen.janky@boystown.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Study Population
Participants will be children in upper elementary and middle school, grades 3 - 8 (~ 8 - 14 years, n = 90). If we have difficulty recruiting an adequate sample of children with hearing and vestibular loss in this age range, we may consider expanding our age range to children 7 to 18 years at enrollment.
All children will receive audiometric assessment (air- and bone-conduction thresholds from 0.25 to 8 kHz) and tympanometry to assess middle ear function. For all experiments, there will be 3 groups, with 30 children in each group: 1) a control group of typically developing children with normal hearing (thresholds ≤ 20 dB HL from 0.25 to 8 kHz) age-matched to, 2) children with hearing loss and normal vestibular function, and 3) children with hearing loss and varying degree of vestibular loss.
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
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.
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.
Other Names:
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]).
|
|
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.
|
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.
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.
Other Names:
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]).
|
|
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).
|
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.
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.
Other Names:
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]).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Dynamic Visual Acuity Test
Time Frame: June 6, 2022 - November 30, 2026
|
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).
|
June 6, 2022 - November 30, 2026
|
|
Reading Ability
Time Frame: June 6, 2022 - November 30, 2026
|
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
|
June 6, 2022 - November 30, 2026
|
|
Static Visual Acuity Test
Time Frame: June 6, 2022 - November 30, 2026
|
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
|
June 6, 2022 - November 30, 2026
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristen L Janky, PhD, Father Flanagan's Boys' Home
Publications and helpful links
General Publications
- Rine RM, Braswell J. A clinical test of dynamic visual acuity for children. Int J Pediatr Otorhinolaryngol. 2003 Nov;67(11):1195-201. doi: 10.1016/j.ijporl.2003.07.004.
- Braswell J, Rine RM. Evidence that vestibular hypofunction affects reading acuity in children. Int J Pediatr Otorhinolaryngol. 2006 Nov;70(11):1957-65. doi: 10.1016/j.ijporl.2006.07.013. Epub 2006 Aug 30.
- Snashall SE. Vestibular function tests in children. J R Soc Med. 1983 Nov;76(11):985-6. doi: 10.1177/014107688307601125. No abstract available.
- Tomaz A, Gananca MM, Garcia AP, Kessler N, Caovilla HH. Postural control in underachieving students. Braz J Otorhinolaryngol. 2014 Apr;80(2):105-10. doi: 10.5935/1808-8694.20140024. English, Portuguese.
- Janky KL, Givens D. Vestibular, Visual Acuity, and Balance Outcomes in Children With Cochlear Implants: A Preliminary Report. Ear Hear. 2015 Nov-Dec;36(6):e364-72. doi: 10.1097/AUD.0000000000000194.
- Aaron PG, Joshi M, Williams KA. Not all reading disabilities are alike. J Learn Disabil. 1999 Mar-Apr;32(2):120-37. doi: 10.1177/002221949903200203.
- Li C, Beaumont JL, Rine RM, Slotkin J, Schubert MC. Normative Scores for the NIH Toolbox Dynamic Visual Acuity Test from 3 to 85 Years. Front Neurol. 2014 Oct 30;5:223. doi: 10.3389/fneur.2014.00223. eCollection 2014.
- Hillman EJ, Bloomberg JJ, McDonald PV, Cohen HS. Dynamic visual acuity while walking in normals and labyrinthine-deficient patients. J Vestib Res. 1999;9(1):49-57.
- Gough, PB, Tunmer, WE (1986). Decoding, reading, and disability. Remedial and Special Education, 7(1), 6-10.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-13-XP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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