NCT05854719

Brief Summary

The goal of this clinical trial is to find out the role of background factors and gaze use in children's speechreading performance. The main questions it aims to answer are:

  • Which background factors and eye gaze patterns are associated with the best speechreading results in hearing children and those with hearing impairment/loss?
  • Are children's gaze patterns and facial expression discrimination associated with interpretation of emotional contents of verbal messages in speechreading?
  • What is the efficacy of intervention that is based on the use of a speechreading application to be developed? Participants will be
  • tested with linguistic and cognitive tests and tasks
  • tested with a speechreading test and tasks with or without simultaneous eye-tracking
  • about half of the participants with hearing impairment/loss will train speechreading with an application Researchers will compare the different age groups and the results of hearing children to those of children with impaired hearing to see if there are differences.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

May 12, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2025

Completed
Last Updated

January 8, 2026

Status Verified

December 1, 2025

Enrollment Period

2.6 years

First QC Date

April 11, 2023

Last Update Submit

January 7, 2026

Conditions

Keywords

hearing impairmentchildspeechreadinglipreadingdevelopmenteye-trackinghearing loss

Outcome Measures

Primary Outcomes (2)

  • Level of speechreading skill

    Score obtained in Children's speechreading test (percent correct, min 0, max 100, higher score indicates better result)

    Two months

  • Level of performance in emotions (facial expressions) + sentence-level speeachreading task

    Score obtained (percent correct, min 0, max 100, higher score indicates better result)

    Two months

Secondary Outcomes (1)

  • Eye gaze use

    Two months

Other Outcomes (1)

  • Level of facial expression discrimination skills

    Two months

Study Arms (3)

Normally hearing children

NO INTERVENTION

No intervention, only initial testing (normal-hearing controls).

Children with hearing impairment/loss with intervention

EXPERIMENTAL

These children participate in speechreading training for two months at home.

Behavioral: Speechreading training with an application

Children with hearing impairment/loss with no intervention

NO INTERVENTION

These children will serve as controls for two months with no speechreading training.

Interventions

The Optic Track application developed for this intervention will be used in speechreading training. The target is that, during the eight intervention weeks, it would be used for 15 minutes at least three times a week.

Children with hearing impairment/loss with intervention

Eligibility Criteria

Age8 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Normally hearing children:
  • age 8-11 years
  • being born full-term (on 37. gestational week or later)
  • Finnish speaking (Finnish is the language the child's family uses at home, the child goes to a school where Finnish is used as the language of instruction)
  • normal hearing and vision
  • typically developing, mainstream education curriculum at school
  • for those tested remotely: computer available at home for remote testing
  • Children with hearing impairment/loss:
  • age 8-11 years
  • diagnosed bilateral hearing impairment
  • being born full-term (on 37. gestational week or later)
  • Finnish speaking (Finnish is the language the child's family uses at home, the child goes to a school where Finnish is used as the language of instruction)
  • normal vision
  • (mainly) typically developing
  • for those tested remotely: computer available at home for remote testing

You may not qualify if:

  • Normally hearing children: psychiatric and neurodevelopmental disorders, including ADHD (Attention Deficit and Hyperacitivity Disorder)
  • Children with hearing impairment/loss: psychiatric and neurodevelopmental disorders (excluding ADHD if medication helps the child to concentrate well during testing)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oulu

Oulu, Finland

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kerttu Huttunen, PhD

    University of Oulu, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Children with hearing impairment/loss are offered with the possibility for a two-month speechreading training at home. Altogether 30 children willing to participate in speechreading training will be recruited into the intervention group. Those not willing to participate in intervention will serve as controls (with no intervention). Normally hearing children will not take part in intervention, they only serve as controls.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2023

First Posted

May 11, 2023

Study Start

May 12, 2023

Primary Completion

December 12, 2025

Study Completion

December 12, 2025

Last Updated

January 8, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations