Intervention for Reduced Sound Tolerance

This study has been completed.
Sponsor:
Collaborators:
University of Maryland
University of Memphis
Information provided by (Responsible Party):
University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier:
NCT00890526
First received: April 28, 2009
Last updated: June 20, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Hyperacusis
Other: Sound Therapy (Tinnitus Retraining Therapy)
Other: Counseling (Tinnitus Retraining Therapy)
Other: No Counseling
Other: Placebo Sound Therapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intervention for Reduced Sound Tolerance

Resource links provided by NLM:


Further study details as provided by University of Alabama, Tuscaloosa:

Primary Outcome Measures:
  • >=dB-10 change in loudness discomfort level. [ Time Frame: 5 consecutive monthly appointments ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in the contour 7. [ Time Frame: 5 consecutive monthly appointments ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2002
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Full treatment = Counseling + sound therapy.
Other: Sound Therapy (Tinnitus Retraining Therapy)
The conventional sound therapy will be achieved with commercially available noise generators. Our clinic uses General Hearing Instruments (OHI) model Tranquil devices as noise sources for TRT. These flexible devices offer an adjustable volume control, with a frequency response extending from ~500 to 8000 Hz. Matched devices will be fitted binaurally and adjusted to each individual ear to achieve audibility of the noise sources (assessed by slight threshold shifts. typically 10- 15 dB, across the audiometric frequency range above 500 Hz). The sound pressure level output and frequency response of each noise source will be measured and documented using both real ear and standard electroacoustic methodologies. Each subject will be carefully instructed as to care of the instruments and correct volume setting. The bilateral noise generators will be used chronically during the intervention period except during sleep.
Other: Counseling (Tinnitus Retraining Therapy)
The directive counseling to be used will include an in-depth participatory discussion with the patient to review audiometric and functional test results, along with the anatomy and physiology of the auditory system. A minimum of two hours will be scheduled to impart this information to the patients so that they will have a clear understanding of the disorder based upon the most current scientific data. The counseling will be focused on educating the patient, neutralizing their negative emotional association with the hyperacusis, and discussing their treatment.
Experimental: 2
Counseling + placebo sound therapy.
Other: Counseling (Tinnitus Retraining Therapy)
The directive counseling to be used will include an in-depth participatory discussion with the patient to review audiometric and functional test results, along with the anatomy and physiology of the auditory system. A minimum of two hours will be scheduled to impart this information to the patients so that they will have a clear understanding of the disorder based upon the most current scientific data. The counseling will be focused on educating the patient, neutralizing their negative emotional association with the hyperacusis, and discussing their treatment.
Other: Placebo Sound Therapy
The placebo sound therapy will use factory-modified GHI Tranquil noise generators, which will appear identical to the conventional Tranquil devices. The placebo Tranquil devices will have a control sensor installed to detect insertion of the device in the ear canal. When the sensor detects the insertion of the placebo device into the ear canal it will trigger gradual decay of the sound output from the placebo device, The time constant of the decaying noise output will be sufficiently long to allow the clinician time to set the volume of each binaural set of devices and to instruct the patient in their use before any noticeable sound attenuation occurs.
Experimental: 3
No Counseling + Sound Therapy
Other: Sound Therapy (Tinnitus Retraining Therapy)
The conventional sound therapy will be achieved with commercially available noise generators. Our clinic uses General Hearing Instruments (OHI) model Tranquil devices as noise sources for TRT. These flexible devices offer an adjustable volume control, with a frequency response extending from ~500 to 8000 Hz. Matched devices will be fitted binaurally and adjusted to each individual ear to achieve audibility of the noise sources (assessed by slight threshold shifts. typically 10- 15 dB, across the audiometric frequency range above 500 Hz). The sound pressure level output and frequency response of each noise source will be measured and documented using both real ear and standard electroacoustic methodologies. Each subject will be carefully instructed as to care of the instruments and correct volume setting. The bilateral noise generators will be used chronically during the intervention period except during sleep.
Other: No Counseling
Patients who are enrolled in Arms 3 and 4 of this study will not be offered directive counseling, but will be fitted with either conventional or placebo noise generators for their sound therapy components. These patients will be told only that their treatment for hyperacusis uses sound therapy. Otherwise, in the instrument fitting appointment (either for the conventional instrument or the placebo device), these patients will receive the same instruction in the care and use of sound generators as those patients enrolled in Treatment Arms 1 and 2 of the clinical trial.
Placebo Comparator: 4
No counseling + Placebo sound therapy.
Other: No Counseling
Patients who are enrolled in Arms 3 and 4 of this study will not be offered directive counseling, but will be fitted with either conventional or placebo noise generators for their sound therapy components. These patients will be told only that their treatment for hyperacusis uses sound therapy. Otherwise, in the instrument fitting appointment (either for the conventional instrument or the placebo device), these patients will receive the same instruction in the care and use of sound generators as those patients enrolled in Treatment Arms 1 and 2 of the clinical trial.
Other: Placebo Sound Therapy
The placebo sound therapy will use factory-modified GHI Tranquil noise generators, which will appear identical to the conventional Tranquil devices. The placebo Tranquil devices will have a control sensor installed to detect insertion of the device in the ear canal. When the sensor detects the insertion of the placebo device into the ear canal it will trigger gradual decay of the sound output from the placebo device, The time constant of the decaying noise output will be sufficiently long to allow the clinician time to set the volume of each binaural set of devices and to instruct the patient in their use before any noticeable sound attenuation occurs.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00890526

Locations
United States, Maryland
Univ. of Maryland - Baltimore
Baltimore, Maryland, United States
Sponsors and Collaborators
University of Alabama, Tuscaloosa
University of Maryland
University of Memphis
  More Information

No publications provided

Responsible Party: University of Alabama, Tuscaloosa
ClinicalTrials.gov Identifier: NCT00890526     History of Changes
Other Study ID Numbers: DC004678, 7R01DC004678-06
Study First Received: April 28, 2009
Last Updated: June 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama, Tuscaloosa:
Tinnitus Retraining Therapy (TRT)

Additional relevant MeSH terms:
Hyperacusis
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014