Frequency CompressionFCNCT04623112
Use of Frequency Compression in Severe-profound Hearing Loss Adults
A study testing Hearing aid feature: Frequency Compression in people with Frequency Compression and Severe-profound Hearing Impairment, run by University College, London.
Trial summary
The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frequency Compression, Severe-profound Hearing Impairment
- What is being tested?
- Hearing aid feature: Frequency Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be over 18 years of age- This study is looking at the use of frequency compression \& its effects of speech perception in adults.
- No ear surgery that would make it impossible to fit a hearing aid- To ensure limited confounding variables.
- No history of ear surgery within the last 12 months- To ensure limited confounding variables.
- No history of ear infection(s) within the last 6 months- To ensure no contraindications and limited confounding variables to testing.
- No otoscopic abnormality making it impossible to fit a hearing aid- To ensure no contraindications to testing.
- Bilateral severe-profound hearing impairment with air conduction thresholds >71dBHL within the frequency range of 250Hz to 4 kHz- To analyse the effects of frequency compression on speech perception within this patient population.
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- Post lingual deafness, with good spoken English- To ensure reliability of speech testing.
- Previous bilateral digital hearing aid experience (6+ months)- To ensure limited confounding variables.
- Written consent required.
Who cannot join
- Participants under the age of 18 years.
- History of ear surgery making it impossible to fit a hearing aid.
- History of ear surgery within the last 12 months.
About this study
Official title: Do Severe-profound Hearing Impaired Adults Perform Better in Speech Perception With Frequency Compression Switched on or Off or Fitted to Hearing Loss
The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.
Read the detailed description
Frequency compression is a feature available on some digital hearing aids, which is aimed at increasing the audibility of high frequency sounds. It works by taking sounds above a fixed start frequency and compresses it into lower frequencies where residual hearing is better.
- Being tested
- Hearing aid feature: Frequency Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing aid feature: Frequency CompressionDevice
Also called Non-linear Frequency Compression
FC Deactivated/Activated \& set to default/Activated \& set to hearing loss
| Study group | Role | What they receive |
|---|---|---|
| FC Deactivated | Other | Frequency Compression feature on hearing aids is deactivated for 4 weeks Receives: Device: Hearing aid feature: Frequency Compression |
| FC activated & set to default | Experimental | Frequency compression feature activated on hearing aids and set to default software settings for 4 weeks. Receives: Device: Hearing aid feature: Frequency Compression |
| FC activated and set to hearing loss | Experimental | Frequency Compression feature activated on hearing aids and set to hearing loss cut-off for 4 weeks Receives: Device: Hearing aid feature: Frequency Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHEAR Auditory Perception Test
Aided Monosyllabic Speech Test
Measured: 4 weeks post hearing aid fitting with adapted hearing aid feature
Adaptive Bamford-Kowal-Bench Test
Aided Sentence Test
Measured: 4 weeks post hearing aid fitting with adapted hearing aid feature
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frequency CompressionStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Vickers, Phd, Study chair, UCL Ear Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623112
- Sponsor's protocol ID
- 15/0217
- Acronym
- FC
- Status last verified
- Nov 2020
- First submitted
- 4 Nov 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Severe-profound Hearing Impaired Adults Perform Better in Speech Perception With Frequency Compression Switched on or Off or Fitted to Hearing Loss
- ClinicalTrials.gov ID
- NCT04623112
- Acronym / sponsor ID
- FC / 15/0217
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 10 Nov 2020 (actual)
- 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 purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.
Detailed description
Frequency compression is a feature available on some digital hearing aids, which is aimed at increasing the audibility of high frequency sounds. It works by taking sounds above a fixed start frequency and compresses it into lower frequencies where residual hearing is better.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FC Deactivated | Other | Device: Hearing aid feature: Frequency CompressionFrequency Compression feature on hearing aids is deactivated for 4 weeks |
| FC activated & set to default | Experimental | Device: Hearing aid feature: Frequency CompressionFrequency compression feature activated on hearing aids and set to default software settings for 4 weeks. |
| FC activated and set to hearing loss | Experimental | Device: Hearing aid feature: Frequency CompressionFrequency Compression feature activated on hearing aids and set to hearing loss cut-off for 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participants must be over 18 years of age- This study is looking at the use of frequency compression \& its effects of speech perception in adults.
- No ear surgery that would make it impossible to fit a hearing aid- To ensure limited confounding variables.
- No history of ear surgery within the last 12 months- To ensure limited confounding variables.
- No history of ear infection(s) within the last 6 months- To ensure no contraindications and limited confounding variables to testing.
- No otoscopic abnormality making it impossible to fit a hearing aid- To ensure no contraindications to testing.
Key exclusion criteria (3 listed)
- Participants under the age of 18 years.
- History of ear surgery making it impossible to fit a hearing aid.
- History of ear surgery within the last 12 months.
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 |
|---|---|---|
| Hearing aid feature: Frequency CompressionAlso: Non-linear Frequency CompressionFC Deactivated/Activated \& set to default/Activated \& set to hearing loss | Device | FC Deactivated, FC activated & set to default, FC activated and set to hearing loss |
Primary outcome
CHEAR Auditory Perception Test
Time frame: 4 weeks post hearing aid fitting with adapted hearing aid feature
Aided Monosyllabic Speech Test
Adaptive Bamford-Kowal-Bench Test
Time frame: 4 weeks post hearing aid fitting with adapted hearing aid feature
Aided Sentence Test
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 10 Nov 2020.
- Individual participant dataSharing planned: Undecided
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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.
Deborah Vickers, Phd study chair
UCL Ear Institute
Questions about this trial
What is this clinical trial studying?
A study testing Hearing aid feature: Frequency Compression in people with Frequency Compression and Severe-profound Hearing Impairment, run by University College, London.
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 9 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 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
CHEAR Auditory Perception Test (time frame: 4 weeks post hearing aid fitting with adapted hearing aid feature). The study lists 2 primary outcomes in all. 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 Nov 2020.