- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04623112
Use of Frequency Compression in Severe-profound Hearing Loss Adults (FC)
November 9, 2020 updated by: University College, London
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
27
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: FC Deactivated
Frequency Compression feature on hearing aids is deactivated for 4 weeks
|
FC Deactivated/Activated & set to default/Activated & set to hearing loss
Other Names:
|
|
Experimental: FC activated & set to default
Frequency compression feature activated on hearing aids and set to default software settings for 4 weeks.
|
FC Deactivated/Activated & set to default/Activated & set to hearing loss
Other Names:
|
|
Experimental: FC activated and set to hearing loss
Frequency Compression feature activated on hearing aids and set to hearing loss cut-off for 4 weeks
|
FC Deactivated/Activated & set to default/Activated & set to hearing loss
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CHEAR Auditory Perception Test
Time Frame: 4 weeks post hearing aid fitting with adapted hearing aid feature
|
Aided Monosyllabic Speech Test
|
4 weeks post hearing aid fitting with adapted hearing aid feature
|
|
Adaptive Bamford-Kowal-Bench Test
Time Frame: 4 weeks post hearing aid fitting with adapted hearing aid feature
|
Aided Sentence Test
|
4 weeks post hearing aid fitting with adapted hearing aid feature
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Deborah Vickers, Phd, UCL Ear Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2015
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
June 1, 2015
Study Registration Dates
First Submitted
November 4, 2020
First Submitted That Met QC Criteria
November 9, 2020
First Posted (Actual)
November 10, 2020
Study Record Updates
Last Update Posted (Actual)
November 10, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/0217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Frequency Compression
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University of FloridaCompletedFruit and Vegetable Selection in the Lunchroom | Consumption Frequency Versus Selection FrequencyUnited States
-
University of FloridaActive, not recruiting
-
The University of Tennessee, KnoxvilleActive, not recruiting
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Sonova AGCompleted
-
University of Castilla-La ManchaHospital Nacional de Parapléjicos de ToledoCompleted
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Prince of Songkla UniversityTerminatedHigh-Frequency VentilationThailand
-
Cairo UniversityUnknown
-
Instituto Politécnico de LeiriaNot yet recruitingFrequency of Treatment Protocol
-
Erasme University HospitalCompletedBronchoscopy | High-Frequency Jet VentilationBelgium
Clinical Trials on Hearing aid feature: Frequency Compression
-
Purdue UniversityRecruiting
-
Sonova AGCompleted
-
Rehear Audiology Company LTDGlobal Edge Medtech Consulting; National Acoustic LaboratoriesRecruitingHearing Impairment, Sensorineural | Perceived Hearing LossAustralia
-
University GhentCompletedHearing Loss, Sensorineural | Speech IntelligibilityBelgium
-
Northwestern UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)Completed
-
Sonova AGCompletedHearing Loss, Sensorineural | Hearing Loss, BilateralCanada
-
Bernafon AGCompletedHearing LossSwitzerland
-
HearX SAWithdrawnHearing Loss | Hearing Impairment
-
Sonova AGCompleted