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NCT02269124 · ClinicalTrials.gov registry record · NA
Use of Amplification in Children With Unilateral Hearing Loss
A NA study, sponsored by Massachusetts Eye and Ear Infirmary.
- Completed
- Registry status
- NA
- Development phase
- 37
- Enrollment target
NCT02269124: Completed NA study, sponsored by Massachusetts Eye and Ear Infirmary.
NCT02269124 is a NA study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 37 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02269124, a NA study, has completed, sponsored by Massachusetts Eye and Ear Infirmary.
- COMPLETED
- Registry status
- NA
- Development phase
- 37 participants
- Enrollment target
Study Summary
Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on quality of life, school performance and behavior. Despite this knowledge, it remains unclear how to best manage this common problem. There has been much debate regarding this issue with many programs recommending preferential seating in the classroom and use of a frequency-modulated (FM) system to amplify the teacher's voice in the classroom (conventional measures), and others recommending these accommodations in addition to use of a hearing aid for amplification (amplification). There is very limited research to support or refute the efficacy of a hearing aid in improving measurable academic, behavioral, or quality-of-life (QOL) outcomes in children with UHL. We propose a study evaluating the impact of hearing aid use in school-aged children (ages 6-12 years) with mild to moderately severe UHL. In this study, subjects will be randomized to receive either conventional measures or conventional measures plus amplification. After a three month period, the groups will be reversed, with each subject serving as their own control. Outcome measurements will include patient reported disease-specific QOL reported by patients, parents, and teachers using validated survey instruments at regular intervals throughout the study period.
Primary Outcome
The HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on quality of life. It is adjusted to a scale of 0-100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. The HEAER-QL-26 was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.
Interventions
- DEVICE Hearing aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2020-03-16 |
| Phase | NA |
What the finished NCT02269124 record still lists
NCT02269124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Hearing aid is the first listed.
NCT02269124 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02269124 about?
NCT02269124 is a clinical study titled "Use of Amplification in Children With Unilateral Hearing Loss". Unilateral hearing loss (UHL) in children has been demonstrated to have a negative impact on quality of life, school performance and behavior. Despite this knowledge, it remains unclear how to best manage this common problem. There has been much debate regarding this issue with many programs recomme...
What is the current status of trial NCT02269124?
This trial is currently completed. It is a NA study. The enrollment target is 37 participants. The study started on 2014-10-01. Estimated completion is 2020-03-16.
What interventions are being tested in trial NCT02269124?
The interventions under investigation include: Hearing aid (DEVICE).
Who is sponsoring clinical trial NCT02269124?
This trial is sponsored by Massachusetts Eye and Ear Infirmary, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02269124's enrollment target sits among peer trials
37 1540th of 2000 higher than 460 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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