Clinical trial NCT05414903: Reading Outcomes in Children With Vestibular Loss
Official title: Reading Outcomes in Children With Vestibular Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Disorder
Hearing Loss, Sensorineural
Lead sponsor: Father Flanagan's Boys' Home
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be children in upper elementary and middle school, grades 3 - 8 (\~ 8 - 14 years, n = 90). 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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The Dynamic Visual Acuity Test
timeFrame: June 6, 2022 - November 30, 2026
measure: Reading Ability
timeFrame: June 6, 2022 - November 30, 2026
measure: Static Visual Acuity Test
timeFrame: June 6, 2022 - November 30, 2026
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Boys Town National Research Hospital
state: Nebraska
Study officials:
affiliation: Father Flanagan's Boys' Home
name: Kristen L Janky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Snashall SE. Vestibular function tests in children. J R Soc Med. 1983 Nov;76(11):985-6. doi: 10.1177/014107688307601125. No abstract available.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Gough, PB, Tunmer, WE (1986). Decoding, reading, and disability. Remedial and Special Education, 7(1), 6-10.