Intervention for Reduced Sound Tolerance

NCT00890526 | Completed Phase 1

• 2 other identifiers: DC0046787R01DC004678-06
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperacusis

Keywords

Tinnitus Retraining Therapy (TRT)

Outcome Measures

Primary Outcomes (1)

• >=dB-10 change in loudness discomfort level.

  5 consecutive monthly appointments

Secondary Outcomes (1)

• Change in the contour 7.

  5 consecutive monthly appointments

Study Arms (4)

1

EXPERIMENTAL

Full treatment = Counseling + sound therapy.

Other: Sound Therapy (Tinnitus Retraining Therapy); Other: Counseling (Tinnitus Retraining Therapy)

2

EXPERIMENTAL

Counseling + placebo sound therapy.

Other: Counseling (Tinnitus Retraining Therapy); Other: Placebo Sound Therapy

3

EXPERIMENTAL

No Counseling + Sound Therapy

Other: Sound Therapy (Tinnitus Retraining Therapy); Other: No Counseling

4

PLACEBO COMPARATOR

No counseling + Placebo sound therapy.

Other: No Counseling; Other: Placebo Sound Therapy

Interventions

Sound Therapy (Tinnitus Retraining Therapy) OTHER

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.

1; 3

Counseling (Tinnitus Retraining Therapy) OTHER

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.

1; 2

No Counseling OTHER

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.

3; 4

Placebo Sound Therapy OTHER

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.

2; 4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• University of Alabama, Tuscaloosa: lead
• University of Maryland: collaborator
• University of Memphis: collaborator

Study Sites (1)

Univ. of Maryland - Baltimore

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Hyperacusis

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2009
• First Posted: April 30, 2009
• Study Start: July 1, 2002
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

US (1)