NCT06913517

Brief Summary

This study examines the comparative effects of hearing aids and cochlear implants on hearing and speech recognition in children with hearing loss. This research adopts a quantitative approach to compare the outcomes of children using hearing aids versus cochlear implants. Data will be collected through audiological evaluations, including aided audiometry and speech recognition tests conducted in an audiology clinic. Descriptive and inferential statistical analyses will be used to determine differences between the groups.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Aided Audiometry

    the hearing ability of individual using hearing aids or cochlear implant is measured in a Free Field Testing Environment using Pure Tones at frequencies 250Hz to 8000Hz. Interpretation: Results are plotted on Audiogram, showing the lowest level in decibel (dB HL) at which patient can detect sounds with their hearing aid or cochlear implant. 20-30dB HL Excellent aided thresholds (satisfactory) 31-40 dBHL Mild aided thresholds (good) 41-60 dBHL Moderate aided hearing thresholds (average) More than 60dBHL Severe aided hearing thresholds (poor)

    12 Months

  • Speech Perception Test

    Evaluated using Phonetically Balanced Monosyllabic word list in Urdu in both quiet and noisy environment. Interpretation: The score is expressed as a percentage of correctly identified words under specified listening condition. 90- 100% Normal or Slight difficulty 70-89% Mild difficulty 50-69% Moderate difficulty Below 50% Severe difficulty or poor word recognition Score

    12 Months

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study examines the comparative effects of hearing aids and cochlear implants on hearing and speech recognition in children with hearing loss. This research adopts a quantitative approach to compare the outcomes of children using hearing aids versus cochlear implants. Data will be collected through audiological evaluations, including aided audiometry and speech recognition tests conducted in an audiology clinic

You may qualify if:

  • Children with 6-18 years of age
  • Bilateral hearing aid users with Moderate to Severe degree Sensorineural hearing loss.
  • Unilateral Cochlear Implant users with Severe to Profound degree Sensorineural hearing loss and no amplification to other ear.
  • Consistent use of hearing aid or cochlear implant for more than 1 year.
  • Known or presumed early onset of hearing loss before 3 years of age
  • Urdu as primary language of education
  • Enrolled in rehabilitation program (school or pre-school for hearing impaired children) focused on oral communication.

You may not qualify if:

  • Children below 6 years or above 18 years
  • Children with less than 1 year of consistent use of hearing aids or cochlear implant
  • Children with cognitive, neurological or developmental disorders."

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Society for Audiological and Developmental Ailments (SADA) - Audiology Clinic

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Speech Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations