Clinical Trial: Use of Amplification in Children With Unilateral Hearing Loss

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Use of Amplification in Children With Unilateral Hearing Loss

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.

Detailed Summary:

Unilateral hearing loss (UHL) is defined as decreased hearing in one ear, with normal hearing thresholds in the contralateral ear. Approximately 0.83/1000 newborn children are found to have UHL. It is estimated that about 3-5% of all children in the United States are eventually diagnosed with UHL. When the cutoff for normal hearing is placed at 15 decibels (dB), this incidence is as high as 6.3%, which corresponds to a prevalence of 6.2 million children nationally. The management of UHL continues to be an area of debate, as the handicap associated with UHL is often underestimated. In fact, those with UHL often go without assistance due to lack of recognition of the disability by some health and educational professionals, who have claimed that this hearing loss "attracts little attention from either patient or parent" and that "these children experience few communicational or educational problems." However, in evaluation of children with permanent hearing loss, rates of children who need speech/language intervention and aural rehabilitation are not significantly different between those with bilateral permanent hearing loss and those with unilateral permanent hearing loss. Unfortunately, children with UHL are half as likely to be referred for hearing testing as those with bilateral hearing loss.

Studies have demonstrated the negative impact of unilateral hearing impairment in children. Educational and behavioral difficulties have been clearly shown, with a number of studies demonstrating increased rates of failure of at least one grade in children with UHL when compared to their classmates with normal hearing (24-35% vs. 3.5%). Additionally, increase in special educational needs (12-41%) and frequent problems with behavior have also been noted in this population. In several studies, Lieu and colleagues have shown poorer performance for children with UHL.
Sponsor: Massachusetts Eye and Ear Infirmary

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome: Same as current

Information By: Massachusetts Eye and Ear Infirmary

Dates:
Date Received: October 16, 2014
Date Started: October 2014
Date Completion: October 2017
Last Updated: April 6, 2017
Last Verified: April 2017