Intervention for Reduced Sound Tolerance
Completed · Phase 1 · Has a placebo group
Conditions studied: Hyperacusis
In brief
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.
Key facts
- Study ID
- NCT00890526
- Run by
- University of Alabama, Tuscaloosa
- People needed
- 36
- Starts
- 2002-07-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2012-06-21
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Univ. of Maryland - Baltimore — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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