跳至主要内容
临床试验/NCT02269124
NCT02269124已完成不适用

Use of Amplification in Children With Unilateral Hearing Loss

Massachusetts Eye and Ear Infirmary2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2014年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
37
试验地点
2
主要终点
LIFE-R Student Questionnaires

研究概览

简要总结

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.

详细描述

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. In a study looking at oral and written language scores, children with UHL did significantly worse than their siblings, who served as matched controls, on language comprehension, oral expression, and oral composite scores. In addition, these children were four times more likely to have Individualized Education Plans (IEPs) and twice as likely to have received speech-language therapy.

Despite these findings regarding the impact of UHL on children, there is a paucity of literature to support or refute the efficacy of hearing aid use in improving measurable academic, behavioral, or quality-of-life (QOL) outcomes. While hearing related disease-specific quality of life measures for children were not developed until very recently, previous studies in adults with UHL reported decreased quality of life, with increased frustration and shame due to hearing disability. The Hearing Environments and Reflection on Quality of Life questionnaire, or HEAR-QL, an instrument developed and validated at Washington University in St. Louis for young children with hearing loss initially (2011) and then later for adolescents (2013), examined effects on environments, activities, and feelings of children with both unilateral and bilateral hearing loss. Significantly lower scores, indicating poorer quality of life, were seen in patients with both UHL and bilateral hearing loss. Interestingly, differences in quality of life between children with UHL and children with bilateral hearing loss were found to be significant in only 1 out of 3 subdomains.

A 2010 study by Johnstone et al. demonstrated that children with UHL who used amplification at a young age (6-9 years) had improvement in localization acuity, while those who received amplification at an older age (10-14 years) noted impairment in localization. This may indicate that the timing of initiation of amplification in UHL may play an important role in whether the intervention is beneficial. In addition, Noh and Park's study in 2012 demonstrated that children with UHL needed to sit 3.5 meters closer to the teacher to obtain the same speech discrimination scores as children with binaural hearing. While this can be accomplished in a small room setting, this may not be possible at all times in all classes, and it is certainly not translatable to hearing environments outside of the classroom. It is not clear whether adding amplification to would eliminate this handicap and improve quality of life, behavior, or academic performance.

Current interventions: Multiple options exist for management of UHL. Preferential seating in the classroom is often the first line of treatment utilized, placing the child at the front of the classroom with the better hearing ear toward the teacher. Evaluation of the classroom by an educational audiologist or other specialist in the education of children with hearing loss in order to optimize the listening environment is another commonly utilized modality for managing UHL. Interventions such as carpeting, tennis balls placed on the legs of chairs, and selection of a classroom with lower ambient noise levels from outside traffic or air handling equipment can reduce significantly improve signal to noise ratios for the student. Another modality for improving signal to noise ration is use of a frequency-modulated (FM) system in the classroom, which specifically amplifies the teacher's voice via a microphone worn by the teacher. This increases the signal-to-noise ratio for the teacher's voice as it does not amplify background noise. Differentiating relevant sound signals from background noise a particularly challenging problem for children with UHL. Other options for management of UHL include various forms of amplification including a unilateral hearing aid, contralateral routing of sound (CROS) systems, and potentially cochlear implantation (though this practice has not been widely adopted in children with UHL in the United States).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

LIFE-R Student Questionnaires

时间窗: 6 months

The LIFE-R Student questionnaire consists of 15 questions that describe situations where hearing difficulty may occur in school. The answers are measured on a scale of 1-5, with 1 indicating situations in which hearing is always difficult and 5 indicating situations where hearing is always easy. The scores are then added standardized from 0 to 100, with lower scores representing a higher frequency of hearing difficulties in the classroom and higher score representing a lower frequency of hearing difficulties. Two versions, the LIFE-R student and the LIFE-R teacher are phrased to apply to the student and the teacher respectively. The LIFE-R Student questionnaire is one of three surveys used to evaluate the primary endpoint: subject-reported quality of life.

HEAR-QL 26 Questionnaire

时间窗: 6 months

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.

CHILD (Child) Questionnaires

时间窗: 6 months

The CHILD (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 total scores across all questions were standardized on a scale of 0 to 100, with lower scores indicating a worse disease-specific quality of life and higher scores signifying a better disease-specific quality of life. Two versions, the CHILD (child) and the CHILD (parent) are phrased to apply to the child and the parent respectively. The CHILD (child) was one of three surveys used to evaluate the study's primary endpoint: subject-reported quality of life.

次要结局

  • LIFE-R Teacher(6 months)
  • CHILD (Parent) Questionnaire(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Cohen

Principal Investigator

Massachusetts Eye and Ear Infirmary

研究点 (2)

Loading locations...

相似试验