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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 is a NA study that has completed, run by Massachusetts Eye and Ear Infirmary. The registered enrollment target is 37 participants.
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.
Interventions
- DEVICE Hearing aid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2020-03-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02269124
The ClinicalTrials.gov registry entry for NCT02269124 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 37 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts Eye and Ear Infirmary, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hearing aid is the first listed.
NCT02269124 reports 0 study locations.
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.
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