Hearing Loss, Noise-InducedHLPPNCT01038336
Hearing Loss Prevention for Veterans
A study testing Multimedia Hearing Loss Prevention Program and Hearing Conservation Brochure in people with Hearing Loss, Noise-Induced, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
Hearing loss is the most prevalent service-connected disability in the VA. It causes communication difficulties, which contribute to isolation, frustration and depression. A major cause of hearing loss is from exposure to high levels of sound, and is referred to as Noise Induced Hearing Loss (NIHL). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Noise-Induced
- What is being tested?
- Multimedia Hearing Loss Prevention Program and Hearing Conservation Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be included in the study all participants will:
- be aged 55 years or less with no exclusions based on ethnicity or gender. The maximum age of 55 years has been selected because hearing conservation programs have the potential to be most effective for younger individuals.
- not use hearing aids
- have cognitive abilities sufficient to participate in the study, as determined by an age/and educationally appropriate score on the Mini Mental State Exam (MMSE).
- ability to read and comprehend the study interventions (HLPP and Hearing conservation brochure) as reflected by a Broad Reading Score of Grade 5 or above on the Woodcock-Johnson III Tests of Achievement Letter-Word Identification, Reading Fluency and Passage Comprehension subtests.
- no known neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review.
- adequate vision to participate in the study as determined with the Smith-Kettlewell Institute Low Luminance (SKILL) Card. Participants will be required to have best corrected vision of 20/63 (mild vision loss) or better.
- openness to using a wearable noise dosimeter and to logging daily activities using a personal digital assistant for three periods of seven days each, as determined by agreement to participate in the study.
Who cannot join
- Individuals will not participate in the study if:
- they are age >55 years.
- wear hearing aids
- score less than the age- and educational-based norms on the MMSE.
- have a Broad Reading score on the Woodcock-Johnson III Tests of Achievement of less than Grade 5.
- have neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study.
- have corrected vision poorer than a Snellen equivalent of 20/63.
- be unwilling to use a wearable noise dosimeter and to logging daily activities using a personal digital assistant for three periods of seven days each.
Trial locations and contacts
1 site in 1 country.
About this study
Hearing loss is the most prevalent service-connected disability in the VA. It causes communication difficulties, which contribute to isolation, frustration and depression. A major cause of hearing loss is from exposure to high levels of sound, and is referred to as Noise Induced Hearing Loss (NIHL). Veterans have inevitably been exposed to high levels of sound during military service, and even though they may not yet have NIHL, their ears have been damaged. Continued noise exposure in civilian life will result in NIHL. However, it can easily be prevented by avoiding noise or using hearing protection. Most people are unaware that noise damages hearing, and even when they are, they do not use hearing protection. In this study we will use a randomized controlled trial to evaluate the short- and long-term effectiveness of two forms of education about NIHL that we have developed for Veterans. One is a computerized program; the other is a Hearing Conservation Brochure
Read the detailed description
Hearing loss and tinnitus are the two most prevalent service-connected disabilities in the VA system for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans, and Veterans from World War II, Korea, Vietnam, the Gulf War and during Peacetime. Costs associated with health care utilization, provision of hearing aids, rehabilitation services and reduced productivity for Veterans with hearing loss are substantial, and continue to increase. On a personal level, hearing loss results in communication difficulties, and often contributes to social isolation, frustration and depression. A major cause of hearing impairment is cochlear damage from exposure to high levels of sound. The longer the period of exposure and the more intense the sound pressure level, the greater is the damage that occurs. The damage from noise exposure is cumulative over time, and exacerbates the effects of aging. Veterans, who have been exposed to high levels of sound in the military are therefore highly vulnerable to damage in civilian life, thus they must protect their ears from further noise to avoid hearing loss as they age. Unfortunately, most people are unaware of the damage noise can do to the auditory system, and even when they are aware, few choose to use hearing protection. It is therefore critical to educate Veterans about the dangers of noise exposure and the simple actions that can be taken to protect hearing.
Our long-range goal is to disseminate an effective hearing loss prevention education program that will help to reduce the prevalence and associated costs of noise induced hearing loss in the Veteran population. Ultimately it is our intention to make the program available to all Veterans, military personnel and other members of the public.
We have developed two forms of intervention to educate Veterans about hearing conservation. One is a computerized multimedia interactive program; the other is a printed Hearing Conservation Brochure. Both provide information about hearing, the damage noise can do to the auditory system, the impact hearing loss has on communication, and the use of hearing protection. In this study we will use a randomized controlled trial to evaluate the effectiveness of these two forms of intervention at changing knowledge, attitudes and behaviors toward hearing conservation. Effectiveness will be examined in three ways through assessment of: (1) actual behavioral changes, as evidenced by decreased daily noise exposure as measured with noise dosimetry; (2) reported behavioral changes, as evidenced by decreased daily noise exposure assessed using a real-time log of daily activities and use of hearing protection; and (3) increased knowledge, healthier attitudes and improved intended and actual behavior towards hearing protection, as assessed with a self-report questionnaire. Outcomes will be measured at baseline, immediately following the intervention and six month post-intervention.
There are many challenges facing military personnel as they reintegrate into society after leaving military service. Reducing their risk of acquiring noise induced hearing loss and the associated problems with communication, will help to make this transition less difficult and traumatic. This study will provide important information about the relative effectiveness of two different forms of hearing conservation education. In the long term it has the potential to reduce the prevalence and associated costs of hearing loss and tinnitus among Veterans, and will demonstrate that prevention of hearing loss can reduce the need for long-term rehabilitation.
- Conditions
- Hearing Loss, Noise-Induced
- Being tested
- Multimedia Hearing Loss Prevention Program, Hearing Conservation Brochure
- Keywords
- Hearing Loss - Noise-Induced, Prevention, Computer-assisted instruction
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimedia Hearing Loss Prevention ProgramBehavioural
Interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
Hearing Conservation BrochureBehavioural
Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
| Study group | Role | What they receive |
|---|---|---|
| Multimedia HLPP | Experimental | Multimedia Hearing Loss Prevention Program (HLPP) Receives: Behavioral: Multimedia Hearing Loss Prevention Program |
| Hearing Conservation Brochure | Active comparator | Hearing Conservation Brochure (HCB) Receives: Behavioral: Hearing Conservation Brochure |
| Standard-of-Care | No intervention | Standard-of-Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Time Spent at Sound Levels >80 Decibels
Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels
Measured: 1 month
Secondary outcomes (7)
Knowledge About Hearing Conservation Scale
Knowledge about hearing conservation was assessed with 16 items in the the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). It is a validated questionnaire that assesses knowledge about and attitudes toward hearing and hearing loss prevention. The Knowledge scale is scored as a percent correct, with a higher score indicating more knowledge. Data presented are for change in knowledge between baseline and 1-month follow-up computed such that a higher score indicates greater increase in knowledge.
Measured: Baseline and 1 month
Change in Perceived Susceptibility Score
Perceived Susceptibility is a construct from the Health Belief Model defined as an individual's assessment of the risk of acquiring a condition. In the current study it assesses the extent to which the individual feels vulnerable to hearing loss. Perceived Susceptibility was assessed with 5 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived susceptibility, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Susceptibility was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived susceptibility at follow-up.
Measured: Baseline and 1 month
Change in Perceived Severity Score
Perceived Severity is a construct from the Health Belief Model defined as an individual's assessment of the seriousness of the consequences of a condition if it is acquired. In the current study it assesses the extent to which the individual believes that a hearing loss would have negative consequences. Perceived Severity was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived severity, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Severity was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived severity at follow-up.
Measured: Baseline and 1 month
Change in Perceived Benefit Score
Perceived Benefit is a construct from the Health Belief Model defined as an individual's assessment of the positive consequences of adopting a health behavior. In the present study that is the belief that hearing well is important. Perceived Benefit was assessed with 7 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived benefit, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived benefit was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived benefit at follow-up.
Measured: Baseline and 1 month
Change in Perceived Barriers Score
Perceived Barriers is a construct from the Health Belief Model defined as an individual's assessment of the influences that discourage adoption of a health behavior. In the current study it assesses the extent to which the individual perceives few negative influences to protecting hearing. Perceived Barriers was assessed with 3 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating fewer perceived barriers, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Barriers was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating fewer perceived barriers at follow-up.
Measured: Baseline and 1 month
Change in Perceived Self-efficacy Score
Perceived Self-efficacy is a construct from the Health Belief Model defined as an individual's assessment of his/her ability to successfully adopt a health behavior. In the current study it assesses the extent to which the individual believes that he/she has the knowledge and abilities to protect hearing. Perceived Self-efficacy was assessed with 4 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater perceived self-efficacy, which according to the Health Belief Model, will increase an individual's likelihood of engaging in a health behavior. Change in Perceived Self-efficacy was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating greater perceived self-efficacy at follow-up.
Measured: Baseline and 1 month
Change in Cues to Action Score
Cues to action is a construct from the Health Belief Model defined as external influences that promote a health behavior (e.g. symptoms, media communications, or information from a healthcare provider). In the current study it refers to prompts from others about protecting hearing. Cues to action was assessed with 2 items in the Knowledge, Attitudes, and Behaviors Questionnaire (KAB; Saunders et al., 2014). Scores for each item are averaged and transformed onto a scale ranging from -50 to +50, with a higher score indicating greater cues to action, which according to the Health Belief Model will increase an individual's likelihood of engaging in a health behavior. Change in Cues to action was computed as the difference between baseline and 1-month follow-up scores, with a higher score indicating more Cues to action having been received at follow-up.
Measured: Baseline and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2009 (estimated)
- Study startMay 2011
- Primary completionJun 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Noise-InducedStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gabrielle H Saunders, Principal investigator, VA Medical Center, Portland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038336
- Sponsor's protocol ID
- C7214-R
- Other IDs
- 11-1408, 02383, 05-2409
- Acronym
- HLPP
- Status last verified
- Nov 2014
- First submitted
- 21 Dec 2009
- Last updated
- 20 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Saunders GH, Griest SE. Hearing loss in veterans and the need for hearing loss prevention programs. Noise Health. 2009 Jan-Mar;11(42):14-21. doi: 10.4103/1463-1741.45308.
PubMed 19265249Folmer RL, Saunders GH, Dann SM, Griest SE, Porsov E, Fausti SA, Leek MR. Guest editorial: Computer-based hearing loss prevention education program for Veterans and military personnel. J Rehabil Res Dev. 2012;49(4):vii-xvi. doi: 10.1682/jrrd.2012.02.0028. No abstract available.
PubMed 22773265Saunders GH, Dann SM, Griest SE, Frederick MT. Development and evaluation of a questionnaire to assess knowledge, attitudes, and behaviors towards hearing loss prevention. Int J Audiol. 2014 Apr;53(4):209-18. doi: 10.3109/14992027.2013.860487. Epub 2014 Jan 27.
PubMed 24467444
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hearing Loss Prevention for Veterans
- ClinicalTrials.gov ID
- NCT01038336
- Acronym / sponsor ID
- HLPP / C7214-R
- Conditions
- Hearing Loss, Noise-Induced
- Keywords
- Hearing Loss - Noise-Induced, Prevention, Computer-assisted instruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- May 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 23 Dec 2009 (estimated)
- Results
- Posted 20 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hearing loss is the most prevalent service-connected disability in the VA. It causes communication difficulties, which contribute to isolation, frustration and depression. A major cause of hearing loss is from exposure to high levels of sound, and is referred to as Noise Induced Hearing Loss (NIHL). Veterans have inevitably been exposed to high levels of sound during military service, and even though they may not yet have NIHL, their ears have been damaged. Continued noise exposure in civilian life will result in NIHL. However, it can easily be prevented by avoiding noise or using hearing protection. Most people are unaware that noise damages hearing, and even when they are, they do not use hearing protection. In this study we will use a randomized controlled trial to evaluate the short- and long-term effectiveness of two forms of education about NIHL that we have developed for Veterans. One is a computerized program; the other is a Hearing Conservation Brochure
Detailed description
Hearing loss and tinnitus are the two most prevalent service-connected disabilities in the VA system for Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans, and Veterans from World War II, Korea, Vietnam, the Gulf War and during Peacetime. Costs associated with health care utilization, provision of hearing aids, rehabilitation services and reduced productivity for Veterans with hearing loss are substantial, and continue to increase. On a personal level, hearing loss results in communication difficulties, and often contributes to social isolation, frustration and depression. A major cause of hearing impairment is cochlear damage from exposure to high levels of sound. The longer the period of exposure and the more intense the sound pressure level, the greater is the damage that occurs. The damage from noise exposure is cumulative over time, and exacerbates the effects of aging. Veterans, who have been exposed to high levels of sound in the military are therefore highly vulnerable to damage in civilian life, thus they must protect their ears from further noise to avoid hearing loss as they age. Unfortunately, most people are unaware of the damage noise can do to the auditory system, and even when they are aware, few choose to use hearing protection. It is therefore critical to educate Veterans about the dangers of noise exposure and the simple actions that can be taken to protect hearing.
Our long-range goal is to disseminate an effective hearing loss prevention education program that will help to reduce the prevalence and associated costs of noise induced hearing loss in the Veteran population. Ultimately it is our intention to make the program available to all Veterans, military personnel and other members of the public.
We have developed two forms of intervention to educate Veterans about hearing conservation. One is a computerized multimedia interactive program; the other is a printed Hearing Conservation Brochure. Both provide information about hearing, the damage noise can do to the auditory system, the impact hearing loss has on communication, and the use of hearing protection. In this study we will use a randomized controlled trial to evaluate the effectiveness of these two forms of intervention at changing knowledge, attitudes and behaviors toward hearing conservation. Effectiveness will be examined in three ways through assessment of: (1) actual behavioral changes, as evidenced by decreased daily noise exposure as measured with noise dosimetry; (2) reported behavioral changes, as evidenced by decreased daily noise exposure assessed using a real-time log of daily activities and use of hearing protection; and (3) increased knowledge, healthier attitudes and improved intended and actual behavior towards hearing protection, as assessed with a self-report questionnaire. Outcomes will be measured at baseline, immediately following the intervention and six month post-intervention.
There are many challenges facing military personnel as they reintegrate into society after leaving military service. Reducing their risk of acquiring noise induced hearing loss and the associated problems with communication, will help to make this transition less difficult and traumatic. This study will provide important information about the relative effectiveness of two different forms of hearing conservation education. In the long term it has the potential to reduce the prevalence and associated costs of hearing loss and tinnitus among Veterans, and will demonstrate that prevention of hearing loss can reduce the need for long-term rehabilitation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multimedia HLPP | Experimental | Behavioral: Multimedia Hearing Loss Prevention ProgramMultimedia Hearing Loss Prevention Program (HLPP) |
| Hearing Conservation Brochure | Active comparator | Behavioral: Hearing Conservation BrochureHearing Conservation Brochure (HCB) |
| Standard-of-Care | No intervention | –Standard-of-Care (SoC) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- be aged 55 years or less with no exclusions based on ethnicity or gender. The maximum age of 55 years has been selected because hearing conservation programs have the potential to be most effective for younger individuals.
- not use hearing aids
- have cognitive abilities sufficient to participate in the study, as determined by an age/and educationally appropriate score on the Mini Mental State Exam (MMSE).
- ability to read and comprehend the study interventions (HLPP and Hearing conservation brochure) as reflected by a Broad Reading Score of Grade 5 or above on the Woodcock-Johnson III Tests of Achievement Letter-Word Identification, Reading Fluency and Passage Comprehension subtests.
- no known neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study as determined by chart review.
Key exclusion criteria (8 listed)
- they are age >55 years.
- wear hearing aids
- score less than the age- and educational-based norms on the MMSE.
- have a Broad Reading score on the Woodcock-Johnson III Tests of Achievement of less than Grade 5.
- have neurological, psychiatric or physical disorders, or co-morbid diseases that would prevent completion of the study.
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 |
|---|---|---|
| Multimedia Hearing Loss Prevention ProgramInteractive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans. | Behavioural | Multimedia HLPP |
| Hearing Conservation BrochureHearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form. | Behavioural | Hearing Conservation Brochure |
Primary outcome
Percentage of Time Spent at Sound Levels >80 Decibels
Time frame: 1 month
Objective measure of noise exposure using dosimeter to measure the percentage of time over 7days spent in sound levels >80 decibels
7 secondary outcomes
Knowledge About Hearing Conservation Scale
Time frame: Baseline and 1 month
Change in Perceived Susceptibility Score
Time frame: Baseline and 1 month
Change in Perceived Severity Score
Time frame: Baseline and 1 month
Change in Perceived Benefit Score
Time frame: Baseline and 1 month
Change in Perceived Barriers Score
Time frame: Baseline and 1 month
Change in Perceived Self-efficacy Score
Time frame: Baseline and 1 month
Change in Cues to Action Score
Time frame: Baseline and 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19265249Saunders GH, Griest SE. Hearing loss in veterans and the need for hearing loss prevention programs. Noise Health. 2009 Jan-Mar;11(42):14-21. doi: 10.4103/1463-1741.45308.
- Results publication: PubMed 22773265Folmer RL, Saunders GH, Dann SM, Griest SE, Porsov E, Fausti SA, Leek MR. Guest editorial: Computer-based hearing loss prevention education program for Veterans and military personnel. J Rehabil Res Dev. 2012;49(4):vii-xvi. doi: 10.1682/jrrd.2012.02.0028. No abstract available.
- Results publication: PubMed 24467444Saunders GH, Dann SM, Griest SE, Frederick MT. Development and evaluation of a questionnaire to assess knowledge, attitudes, and behaviors towards hearing loss prevention. Int J Audiol. 2014 Apr;53(4):209-18. doi: 10.3109/14992027.2013.860487. Epub 2014 Jan 27.
Related trials for Hearing Loss, Noise-Induced
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Not yet recruiting
Intervention for Hearing Health Among Native Americans
Noise-Induced Hearing Loss
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Recruiting
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Noise Exposure, Noise-induced Hearing Loss
RecruitingPhase 1/2
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Central Auditory Processing Disorder, Hearing Impaired (Partially)
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.
Gabrielle H Saunders principal investigator
VA Medical Center, Portland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimedia Hearing Loss Prevention Program and Hearing Conservation Brochure in people with Hearing Loss, Noise-Induced, run by US Department of Veterans Affairs 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 8 inclusion and 8 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 20 Nov 2014. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Time Spent at Sound Levels >80 Decibels (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01038336, which also lists 3 linked publications.
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 20 Nov 2014; AzTrials last refreshed its copy on 29 Oct 2026.