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Use of Amplification in Children With Unilateral Hearing Loss

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ClinicalTrials.gov Identifier: NCT02269124
Recruitment Status : Recruiting
First Posted : October 20, 2014
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Michael Cohen, Massachusetts Eye and Ear Infirmary

Brief 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.

Condition or disease Intervention/treatment Phase
Unilateral Hearing Loss Device: Hearing aid Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Amplification in Children With Unilateral Hearing Loss
Study Start Date : October 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

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Arm Intervention/treatment
No Intervention: Conventional measures arm
In arm 1, the child will utilize conventional measures for management of unilateral hearing loss, such as FM system and preferential seating in the classroom. While two basic types of FM systems exist, personal and sound field, subjects in our study will utilize a personal FM system, worn at the ear-level. This will increase the likelihood that the child will receive amplification in all classes, and will help to standardize this intervention. The HEAR-QL, CHILD (child) questionnaire, and LIFE-R student questionnaire will be administered to the child at the beginning, midpoint, and conclusion of this 3-month arm via Redcap. The CHILD (parent) questionnaire will be administered to the parent and the LIFE-R teacher questionnaire will be administered to the teacher at the same intervals.
Experimental: Conventional measures + hearing aid arm
In the second arm, the child will use the conventional measures described above in addition to a digital behind-the-ear hearing aid with a standard ear hook and custom ear mold on the affected ear. The hearing instrument will be customized by a Massachusetts Eye and Ear Infirmary (MEEI) audiologist. The subject will be instructed wear the hearing aid both at home and at school. In both arms, the FM system will be used in school only. As in the first arm, the HEAR-QL, CHILD (child) questionnaire, and LIFE-R student questionnaire will be administered to the child at the beginning, midpoint, and conclusion of this 3-month arm. The CHILD (parent) questionnaire will be administered to the parent and the LIFE-R teacher questionnaire will be administered to the teacher at the same intervals.
Device: Hearing aid
The subject will wear a hearing aid at all times for a 3-month period. At school, he/she will wear this hearing aid in addition to using conventional measures (FM system and preferential seating).




Primary Outcome Measures :
  1. HEAR-QL 26 questionnaire [ Time Frame: 3 months ]
    The HEAR-QL consists of 28 items that measure the perceived effect of hearing loss on the 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.


Secondary Outcome Measures :
  1. CHILD questionnaires [ Time Frame: 3 months ]
    The CHILD questionnaire consists of 15 questions that describe situations where hearing difficulty may occur when the child is with his/her family. The answers are measured on a scale of 1-8, with 1 indicating poor ability to hear, and 8 indicating complete understanding. The scores are added and divided by 15, giving a final score on a scale of 1-8. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively.

  2. LIFE-R questionnaires [ Time Frame: 3 months ]
    The LIFE-R questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 0-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added and measured overall on a scale of 0-75. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively.



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Children ages 6-12 years with mild to moderately severe unilateral hearing loss, with thresholds across 4 frequencies ≥ 25 dB but < 70 dB in the worse hearing ear; Normal hearing in the contralateral ear, defined as thresholds ≤ 20 dB from 250 Hz to 8000 Hz; Unaided word recognition scores of ≥ 80% in worse hearing ear

Exclusion Criteria:

Contralateral hearing loss; Significant cognitive impairment; Middle ear disease that has not been addressed; Inability to commit to treatment program


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02269124


Contacts
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Contact: Evette Ronner 617-573-3576 evette_ronner@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Evette Ronner    617-573-3576    evette_ronner@meei.harvard.edu   
Principal Investigator: Michael S Cohen, MD         
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Michael Cohen, MD Massachusetts Eye and Ear Infirmary

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Responsible Party: Michael Cohen, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02269124     History of Changes
Other Study ID Numbers: 14-006H
First Posted: October 20, 2014    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Unilateral
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms