Hearing LossNCT02109757
Evaluation of Hearing Protection Fit Testing Program
A study testing Software intervention and education and Education only in people with Hearing Loss, run by United States Air Force at 2 sites in United States.
Trial summary
The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Software intervention and education and Education only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2014to Oct 2015
- Phase
- Interventional
- 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
- Subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. Subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction.
Who cannot join
- Not enrolled in the hearing conservation program. Not using in-the-ear hearing protection device on a regular basis. Ear canals containing cerumen, infection, or other obstructions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Wright-Patterson Air Force Base
Dayton, Ohio, 45433
Quintin A Hecht, Au.D., 937-938-3201, quintin.hecht.1@us.af.mil
Quintin A Hecht, Au.D.
- Recruiting
Elmendorf Air Force Base
Elemendorf Air Force Base, Alaska
Shannon Hunt, Au.D., 907-580-5804, shannon.hunt.3@us.af.mil
Shannon Hunt, Au.D.
About this study
The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force (USAF) employees. Currently, Public Health provides informal, subjective training to employees; this practice may be altered by the results of this study.
- Conditions
- Hearing Loss
- Being tested
- Software intervention and education, Education only
- Keywords
- Hearing conservation, Personal attenuation rating, earplug
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software intervention and educationOther
Personal attenuation rating measurements will be taken before and after educating the patient using software program
Education onlyOther
| Study group | Role | What they receive |
|---|---|---|
| Software intervention and education | Experimental | This group will receive software intervention and education before and after receiving one-on-one education, thus showing if benefit or effect occurs simply due to having the software input before receiving education. Receives: Other: Software intervention and education |
| Education only | Active comparator | This group will not receive software intervention prior to and after one-on-one education, only afterwards. Receives: Other: Education only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.
The experimental group will show an increase, larger than the control group, in the amount of personal attenuation rating measurement shown by the software program as a result of software intervention used before and after education at the initial and follow-up visits.
Measured: 6 mos after intial subject visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Air Force
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Quintin Hecht, United States Air Force
- Investigators
- Quintin A Hecht, Au.D., Principal investigator, United States Air Force School of Aerospace Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109757
- Sponsor's protocol ID
- FWR20130114H
- Status last verified
- Apr 2014
- First submitted
- 9 Jan 2014
- Last updated
- 10 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hearing Protection Fit Testing Program
- ClinicalTrials.gov ID
- NCT02109757
- Acronym / sponsor ID
- FWR20130114H
- Conditions
- Hearing Loss
- Keywords
- Hearing conservation, Personal attenuation rating, earplug
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- United States Air ForceUS federal agency
- Study start
- Mar 2014
- Primary completion
- Oct 2015 (estimated)
- First posted
- 10 Apr 2014 (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.
The specific aim of this research is to evaluate the performance, effectiveness, and long-term training benefits of a formal hearing protection fit testing program. This study may provide preliminary evidence on the benefits of direct education/training combined with a formal hearing protection device (HPD) fit testing on HPD fittings on United States Air Force (USAF) employees. Currently, Public Health provides informal, subjective training to employees; this practice may be altered by the results of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Software intervention and education | Experimental | Other: Software intervention and educationThis group will receive software intervention and education before and after receiving one-on-one education, thus showing if benefit or effect occurs simply due to having the software input before receiving education. |
| Education only | Active comparator | Other: Education onlyThis group will not receive software intervention prior to and after one-on-one education, only afterwards. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be enrolled in the hearing conservation program, and can be civilian or active duty/uniformed. Subjects must be currently using some form of in-the-ear hearing protection device on a regular basis and have ear canals free of cerumen, infection, or any other obstruction.
Key exclusion criteria (1 listed)
- Not enrolled in the hearing conservation program. Not using in-the-ear hearing protection device on a regular basis. Ear canals containing cerumen, infection, or other obstructions.
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 |
|---|---|---|
| Software intervention and educationPersonal attenuation rating measurements will be taken before and after educating the patient using software program | Other | Software intervention and education |
| Education only | Other | Education only |
Primary outcome
Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating.
Time frame: 6 mos after intial subject visit
The experimental group will show an increase, larger than the control group, in the amount of personal attenuation rating measurement shown by the software program as a result of software intervention used before and after education at the initial and follow-up visits.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2014.
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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.
Elmendorf Air Force Base
Elemendorf Air Force Base, United States
Quintin A Hecht, Au.D. principal investigator
United States Air Force School of Aerospace Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Software intervention and education and Education only in people with Hearing Loss, run by United States Air Force at 2 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of earplug fit for participants in the Air Force Hearing Conservation Program as a measure of education and personnal attenuation rating. (time frame: 6 mos after intial subject visit). 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 10 Apr 2014.