Auditory PerceptionNCT03704142
Comparison of PSAPs in Different Maskers
A study testing Sound World Solutions CS50+, Tweak Focus and IQ Earbuds in people with Auditory Perception, run by University of Massachusetts, Amherst at 1 site in United States.
Trial summary
This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels. Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Perception
- What is being tested?
- Sound World Solutions CS50+, Tweak Focus and IQ Earbuds
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Mar 2020
- 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 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- mild high-frequency hearing loss (pure-tone thresholds of 25 decibels hearing loss - 45 decibels hearing loss between 2000 Hz and 6000 Hz)
Who cannot join
- history of prior hearing aid use
- history of neurologic or otologic disorders
- score of < 26 on Montreal Cognitive Assessment (cognitive screening tool)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Amherst
Amherst, Massachusetts, 01003
About this study
Official title: Personal Amplification Devices in Noise and Speech Maskers
This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels.
Read the detailed description
Speech understanding will be measured both unaided and aided with three different models of Personal Amplification devices (PSAPs). Sentences will be played to the participant from a loudspeaker located in front. Different types of background sounds (noise and other sentences) will be played from loudspeakers located to the right and left of the participant. Participants will be instructed to repeat back the sentence coming from the front. They also will rate subjective effort at the end of each block of trials.
- Conditions
- Auditory Perception
- Being tested
- Sound World Solutions CS50+, Tweak Focus, IQ Earbuds, Bose Hearphones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound World Solutions CS50+Device
Participants will be tested using the Sound World Solutions CS 50+ hearing devices.
Tweak FocusDevice
Participants will be tested using the Tweak Focus hearing devices.
IQ EarbudsDevice
Participants will be tested using the IQ Earbuds hearing devices.
Bose HearphonesDevice
Participants will be tested using the Bose Hearphones hearing devices.
| Study group | Role | What they receive |
|---|---|---|
| Tweak Focus | Experimental | Speech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers. Receives: Device: Tweak Focus |
| IQ Earbuds | Experimental | Speech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers. Receives: Device: IQ Earbuds |
| Sound World Solutions CS50+ | Experimental | Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. Receives: Device: Sound World Solutions CS50+ |
| Bose Hearphones | Experimental | Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. Receives: Device: Bose Hearphones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise
Improvement in performance on speech perception task using the Nuheara IQ Buds, Tweak Focus, Bose Hearphones, or the Sound World Solutions CS 50+ personal listening devices, measured by percentage of words accurately recalled in noise with device minus percentage recalled without device. Positive values indicate improvement in performance.
Measured: One 2-hour lab session
Secondary outcomes (1)
Difference in Self-rated Listening Effort
Effect of listening devices on subjective listening effort, measured by rating on ten-point scale (10 = greatest amount of effort) after task performed with device minus rating after task performed without device. Lower scores indicate less listening effort; negative values indicate reduction in effort with device.
Measured: One 2-hour session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2018
- Study start1 Mar 2019
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
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.
- Other trials for Auditory PerceptionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Each participant will be tested with one of the models of devices.
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Helfer, University of Massachusetts, Amherst
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03704142
- Sponsor's protocol ID
- UMassAmherst
- Status last verified
- Feb 2022
- First submitted
- 6 Sep 2018
- Last updated
- 17 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personal Amplification Devices in Noise and Speech Maskers
- ClinicalTrials.gov ID
- NCT03704142
- Acronym / sponsor ID
- UMassAmherst
- Conditions
- Auditory Perception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 12 Oct 2018 (actual)
- Results
- Posted 17 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will measure the performance of three personal amplification devices when used by middle-aged adults. Speech understanding will be assessed with two different types of background noises at three different input levels.
Detailed description
Speech understanding will be measured both unaided and aided with three different models of Personal Amplification devices (PSAPs). Sentences will be played to the participant from a loudspeaker located in front. Different types of background sounds (noise and other sentences) will be played from loudspeakers located to the right and left of the participant. Participants will be instructed to repeat back the sentence coming from the front. They also will rate subjective effort at the end of each block of trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Each participant will be tested with one of the models of devices.
| Arm | Type | Receives |
|---|---|---|
| Tweak Focus | Experimental | Device: Tweak FocusSpeech understanding and listening effort will be assessed using the Tweak Focus personal sound amplifiers. |
| IQ Earbuds | Experimental | Device: IQ EarbudsSpeech understanding and listening effort will be assessed using the IQEarbuds personal sound amplifiers. |
| Sound World Solutions CS50+ | Experimental | Device: Sound World Solutions CS50+Speech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. |
| Bose Hearphones | Experimental | Device: Bose HearphonesSpeech understanding and listening effort will be assessed using the Sound World Solutions CS50+ personal sound amplifiers. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- mild high-frequency hearing loss (pure-tone thresholds of 25 decibels hearing loss - 45 decibels hearing loss between 2000 Hz and 6000 Hz)
Key exclusion criteria (3 listed)
- history of prior hearing aid use
- history of neurologic or otologic disorders
- score of < 26 on Montreal Cognitive Assessment (cognitive screening tool)
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 World Solutions CS50+Participants will be tested using the Sound World Solutions CS 50+ hearing devices. | Device | Sound World Solutions CS50+ |
| Tweak FocusParticipants will be tested using the Tweak Focus hearing devices. | Device | Tweak Focus |
| IQ EarbudsParticipants will be tested using the IQ Earbuds hearing devices. | Device | IQ Earbuds |
| Bose HearphonesParticipants will be tested using the Bose Hearphones hearing devices. | Device | Bose Hearphones |
Primary outcome
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise
Time frame: One 2-hour lab session
Improvement in performance on speech perception task using the Nuheara IQ Buds, Tweak Focus, Bose Hearphones, or the Sound World Solutions CS 50+ personal listening devices, measured by percentage of words accurately recalled in noise with device minus percentage recalled without device. Positive values indicate improvement in performance.
1 secondary outcome
Difference in Self-rated Listening Effort
Time frame: One 2-hour session
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 study testing Sound World Solutions CS50+, Tweak Focus and IQ Earbuds in people with Auditory Perception, run by University of Massachusetts, Amherst 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 1 inclusion and 3 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 17 May 2022. 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 17 May 2022). 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?
Comparison of How Four Models of Personal Listening Devices Improve Word Understanding in Noise (time frame: One 2-hour lab session). 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 17 May 2022.