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Vestibular DisorderNCT05414903

Reading Outcomes in Children With Vestibular Loss

A study testing Dynamic Visual Acuity, Reading Outcomes and Static Visual Acuity in people with Vestibular Disorder and Hearing Loss, Sensorineural, run by Father Flanagan's Boys' Home at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 18 yearsHealthy volunteers can take part
What is being tested?
Dynamic Visual Acuity, Reading Outcomes and Static Visual Acuity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
6 Jun 2022to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Kristen L Janky, PhD contact

15313556535

kristen.janky@boystown.org

Jessie N Patterson, PhD contact

15313556333

jessie.patterson@boystown.org

United States1 site, 1 recruiting
  • Boys Town National Research Hospital

    Omaha, Nebraska, 68131

    Kristen L Janky, PhD, 15313556535, kristen.janky@boystown.org

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Vestibular loss can co-occur with hearing loss causing dual sensory deficits. Unfortunately, children with hearing loss are rarely assessed for vestibular loss. As a result, the impact of co-morbid vestibular loss in children with hearing loss is unknown, particularly on academic and cognitive outcomes. While vestibular loss has been speculated to affect reading outcomes in children (Braswell 2006a; Snashall 1983; Tomaz 2014), the extent to which vestibular loss affects reading outcomes and the association between vestibular loss and reading is not understood. Therefore, the purpose of this proposal is to investigate the relationship between reading outcomes and vestibular loss in children with hearing loss. The vestibular system is responsible for decoding head movement and eliciting eye movements in an equal and opposite direction to maintain steady vision. It is not surprising therefore that vestibular loss results in reduced dynamic visual acuity - the ability to see clearly during head movement - (Rine 2003; Janky 2015); however, children with vestibular loss and reduced dynamic visual acuity also have reduced reading acuity - the smallest print size that can be read - and require larger print size for reading compared to peers with normal hearing (Braswell 2006a). Thus, Aim 1 will test the hypothesis that vestibular loss results in visual acuity deficits due to vestibulo-ocular reflex and cognitive deficits, which could impact reading. Theoretically, the Simple View of Reading (Gough 1986) suggests that reading comprehension can be explained by decoding and language comprehension abilities; however, these two factors do not account for all the variance in reading comprehension (Aaron 1999). In children with hearing loss, reading is affected by language, phonological processing, and auditory access; however, these factors alone do not fully explain the variance. Aim 2 will test the hypothesis that after controlling for variables known to contribute to reading performance (i.e., language, phonological processing, auditory access, etc.), vestibular loss will account for a significant amount of the variance in reading outcomes. The long-term goals of this research program are to define the developmental and academic impact of comorbid vestibular loss and then develop rehabilitative strategies that mitigate negative outcomes. The proposed work will provide a better understanding of vestibular loss as a contributing factor to reading difficulties for children with hearing loss, where previously only the effects of hearing loss have been considered. The proposed work will improve the scientific understanding of reading deficits in children with hearing loss and could lead to new rehabilitative interventions for reading in children with hearing loss by considering vestibular loss, a factor that has until now been ignored. A scaffolded training plan has been devised to enhance the investigator's understanding of literacy outcomes in children with hearing loss, cognition, neuroanatomy, development, and the ability to incorporate eye tracking to address the hypotheses.

Being tested
Dynamic Visual Acuity, Reading Outcomes, Static Visual Acuity
Medical subject headings
Vestibular Diseases, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dynamic Visual AcuityBehavioural

    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 OutcomesBehavioural

    Also called 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

    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 AcuityBehavioural

    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 groups in NCT05414903
Study groupRoleWhat they receive
Children with Normal HearingActive comparatortypically developing children with normal hearing (thresholds ≤ 20 dB HL from 0.25 to 8 kHz) age-matched to the children with hearing loss
Receives: Behavioral: Dynamic Visual Acuity; Behavioral: Reading Outcomes; Behavioral: Static Visual Acuity
Children with hearing loss and normal vestibular functionActive comparatorChildren with hearing loss will have a pure-tone average (PTA) > 65 dB and normal vestibular evaluation.
Receives: Behavioral: Dynamic Visual Acuity; Behavioral: Reading Outcomes; Behavioral: Static Visual Acuity
children with hearing loss and vestibular lossExperimentalChildren with hearing loss will have a pure-tone average (PTA) > 65 dB and and varying degree of vestibular loss (i.e., unilateral or bilateral).
Receives: Behavioral: Dynamic Visual Acuity; Behavioral: Reading Outcomes; Behavioral: Static Visual Acuity

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: June 6, 2022 - November 30, 2026

  2. 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

    Measured: June 6, 2022 - November 30, 2026

  3. 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

    Measured: June 6, 2022 - November 30, 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start6 Jun 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Model description
"Single Group" has been selected because all study participants will get the same intervention.
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414903
Sponsor's protocol ID
12-13-XP
Status last verified
Dec 2025
First submitted
6 Jun 2022
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that are included in any publications.

Publications

  • 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.

    PubMed 16945429
  • Snashall SE. Vestibular function tests in children. J R Soc Med. 1983 Nov;76(11):985-6. doi: 10.1177/014107688307601125. No abstract available.

    PubMed 20894507
  • 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.

    PubMed 24830967
  • 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.

    PubMed 14597370
  • 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.

    PubMed 26182202
  • 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.

    PubMed 15499713
  • 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.

    PubMed 25400618
  • 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.

    PubMed 10334016
  • Gough, PB, Tunmer, WE (1986). Decoding, reading, and disability. Remedial and Special Education, 7(1), 6-10.

Questions about this trial

What is this clinical trial studying?

A study testing Dynamic Visual Acuity, Reading Outcomes and Static Visual Acuity in people with Vestibular Disorder and Hearing Loss, Sensorineural, run by Father Flanagan's Boys' Home at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kristen L Janky, PhD (15313556535, kristen.janky@boystown.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Dynamic Visual Acuity Test (time frame: June 6, 2022 - November 30, 2026). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05414903, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.

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