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临床试验/NCT00890526
NCT00890526已完成1 期

Intervention for Reduced Sound Tolerance

University of Alabama, Tuscaloosa1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2002年7月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
>=dB-10 change in loudness discomfort level.

研究概览

简要总结

Hyperacusis is the intolerance to sound levels that normally are judged acceptably loud to others. The presence of hyperacusis (diagnosed or undiagnosed) can be an important reason why some persons reject amplified sound from hearing aids. Tinnitus Retraining Therapy (TRT), originally proposed for the treatment of persons with debilitating tinnitus, offers the significant secondary benefit of increased Loudness Discomfort Levels (LDLs), along with expansion of the dynamic range for loudness. TRT uses both counseling and sound therapy from daily exposure to soft sound from bilateral noise generator devices (NGs) and has been promoted as an intervention for hyperacusis. The hypothesis of this investigational study is that the counseling and sound therapy principles used in TRT can be applied successfully to treat hearing-impaired hearing-aid candidates with reduced sound tolerance who are otherwise should benefit from hearing aids.

详细描述

Hyperacusis is the intolerance to sound levels that normally are judged acceptably loud to others. The presence of hyperacusis (diagnosed or undiagnosed) can be an important reason why some persons reject amplified sound from hearing aids. Tinnitus Retraining Therapy (TRT), originally proposed for the treatment of persons with debilitating tinnitus, offers the significant secondary benefit of increased Loudness Discomfort Levels (LDLs), along with expansion of the dynamic range for loudness. TRT uses both counseling and sound therapy from daily exposure to soft sound from bilateral noise generator devices (NGs) and has been promoted as an intervention for hyperacusis. The hypothesis of this investigational study is that the counseling and sound therapy principles used in TRT can be applied successfully to treat hearing-impaired hearing-aid candidates with reduced sound tolerance who are otherwise should benefit from hearing aids.

The current study is being implemented as a randomized, double-blind, placebo-controlled trial to assess the efficacy of a TRT-based intervention for reduced sound tolerance in hearing-aid eligible persons with hyperacusis and/or restricted dynamic ranges. The trial design allows for the evaluation of the efficacy of partial treatments, including the effects of counseling separately from the effects of sound therapy. Forty hearing-impaired subjects (without primary tinnitus) are being assigned randomly to one of four treatment groups: 1) full treatment, both counseling and sound-therapy (n=10); 2) counseling with placebo sound therapy (n=10); 3) sound therapy without counseling (n=10); and 4) placebo sound therapy without counseling (n=10). Subjects are being evaluated at least monthly, typically for five months or more, on a variety of audiometric tests, including LDLs, the Contour Test for Loudness for tones and speech, word recognition measured at each session's comfortable and loud levels, and electrophysiological measures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • One hundred adults, who have hearing losses and who have unsuccessfully used hearing aids because of tolerance problems (hyperacusis).
  • All subjects must be committed to the use of amplification if and when the hyperacusis is resolved.
  • Each patient will have demonstrable hyperacusis, but will be free from tinnitus, and must be willing to wear and usc binaural in-the-ear sound generators (or placebo generators) chronically as prescribed.

排除标准

  • Evidence of conductive, mixed hearing loss, or CNS disease.
  • Abnormal tone and/or acoustic reflex decay will also preclude subject participation because of the potential for these patients to adapt to the chronic sound therapy.

结局指标

主要结局

>=dB-10 change in loudness discomfort level.

时间窗: 5 consecutive monthly appointments

次要结局

  • Change in the contour 7.(5 consecutive monthly appointments)

研究者

发起方
University of Alabama, Tuscaloosa
申办方类型
Other
责任方
Sponsor

研究点 (1)

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