HyperacusisPhase 1NCT00890526
Intervention for Reduced Sound Tolerance
A Phase 1 study testing Sound Therapy (Tinnitus Retraining Therapy), Counseling (Tinnitus Retraining Therapy) and No Counseling in people with Hyperacusis, run by University of Alabama, Tuscaloosa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hyperacusis
- What is being tested?
- Sound Therapy (Tinnitus Retraining Therapy), Counseling (Tinnitus Retraining Therapy) and No Counseling
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2002to Sep 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hyperacusis
- Being tested
- Sound Therapy (Tinnitus Retraining Therapy), Counseling (Tinnitus Retraining Therapy), No Counseling, Placebo Sound Therapy
- Keywords
- Tinnitus Retraining Therapy (TRT)
- Medical subject headings
- Hyperacusis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
No CounselingOther
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 Sound TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Full treatment = Counseling + sound therapy. Receives: Other: Sound Therapy (Tinnitus Retraining Therapy); Other: Counseling (Tinnitus Retraining Therapy) |
| 2 | Experimental | Counseling + placebo sound therapy. Receives: Other: Counseling (Tinnitus Retraining Therapy); Other: Placebo Sound Therapy |
| 3 | Experimental | No Counseling + Sound Therapy Receives: Other: Sound Therapy (Tinnitus Retraining Therapy); Other: No Counseling |
| 4 | Placebo comparator | No counseling + Placebo sound therapy. Receives: Other: No Counseling; Other: Placebo Sound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
>=dB-10 change in loudness discomfort level.
Measured: 5 consecutive monthly appointments
Secondary outcomes (1)
Change in the contour 7.
Measured: 5 consecutive monthly appointments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startJul 2002
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperacusisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama, Tuscaloosa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, University of Memphis
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890526
- Sponsor's protocol ID
- DC004678
- Other IDs
- 7R01DC004678-06
- Status last verified
- Jun 2012
- First submitted
- 28 Apr 2009
- Last updated
- 21 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention for Reduced Sound Tolerance
- ClinicalTrials.gov ID
- NCT00890526
- Acronym / sponsor ID
- DC004678
- Conditions
- Hyperacusis
- Keywords
- Tinnitus Retraining Therapy (TRT)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of Alabama, TuscaloosaUniversity, hospital or other
- Collaborators
- University of Maryland, University of Memphis
- Study start
- Jul 2002
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Sound Therapy (Tinnitus Retraining Therapy), Other: Counseling (Tinnitus Retraining Therapy)Full treatment = Counseling + sound therapy. |
| 2 | Experimental | Other: Counseling (Tinnitus Retraining Therapy), Other: Placebo Sound TherapyCounseling + placebo sound therapy. |
| 3 | Experimental | Other: Sound Therapy (Tinnitus Retraining Therapy), Other: No CounselingNo Counseling + Sound Therapy |
| 4 | Placebo comparator | Other: No Counseling, Other: Placebo Sound TherapyNo counseling + Placebo sound therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 1, 3 |
| 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 | 1, 2 |
| No CounselingPatients 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 | 3, 4 |
| Placebo Sound TherapyThe 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. | Other | 2, 4 |
Primary outcome
>=dB-10 change in loudness discomfort level.
Time frame: 5 consecutive monthly appointments
1 secondary outcome
Change in the contour 7.
Time frame: 5 consecutive monthly appointments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sound Therapy (Tinnitus Retraining Therapy), Counseling (Tinnitus Retraining Therapy) and No Counseling in people with Hyperacusis, run by University of Alabama, Tuscaloosa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
>=dB-10 change in loudness discomfort level. (time frame: 5 consecutive monthly appointments). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2012.