Cochlear Hearing Loss Clinical Trial
Official title:
A Comparison of Conventional Hearing Aid Processing (CP) and Non-linear Frequency Compression (NLFC) Processing in Adult Patients With and Without Cochlear Dead Regions Who Have a Moderate to Severe Sensorineural Hearing Loss.
NCT number | NCT04145661 |
Other study ID # | B00700 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 20, 2019 |
Est. completion date | March 26, 2020 |
Verified date | May 2020 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The investigators are interested in an additional hearing aid feature called non-linear
frequency compression (NLFC). This aims to improve audibility of high frequency sounds by
converting them into lower frequencies and has been shown to benefit those with
moderate-severe sensorineural hearing loss (SNHL). Cochlear dead regions (DRs) are areas of
the inner hearing organ (the cochlea) where there is little or no function and are commonly
found in regions responsible for detecting high pitched (frequency) sounds.
Not all people with hearing loss have DRs. The investigators would like to determine whether
based on the presence or absence of DRs, patients with moderate-severe SNHL perform better or
prefer their hearing aids programmed conventionally, or with NLFC activated. To do this, two
participant groups will be created based on findings from the threshold equalising noise
(TEN) test which identifies cochlear DRs. Two participant groups will be created; one group
with DRs and one group without DRs.
All participants will receive two hearing aids and will wear these programmed conventionally
for ~six weeks and with NLFC activated for ~six weeks in a counterbalanced manner. Following
each condition, participants will complete a questionnaire and various speech tests will be
performed. This involves participants repeating sentences, words or speech sounds they hear
from a speaker in quiet and in the presence of background noise. Individuals' scores will be
calculated for each test and their performance when NLFC was activated and deactivated will
be compared. This will be analysed alongside the questionnaire data to compare the 'DR' and
'no DR' group in both conditions. Findings may help to determine whether NLFC should be
activated for all moderate-severe SNHL patients, or just those with DRs, helping clinicians
to optimise hearing aid settings for patients.
Status | Completed |
Enrollment | 11 |
Est. completion date | March 26, 2020 |
Est. primary completion date | March 26, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 44 Years and older |
Eligibility |
Inclusion Criteria: - Aged 45 years and above. - Bilateral moderate to severe symmetrical sensorineural hearing loss, defined as PTA thresholds from 0.5- 4kHz falling between 40dB and 85dB. - Normal otoscopic examination and normal middle ear function. - Currently wears bilateral hearing aids. - Good hearing aid user >5 hours a day bilaterally, assessed by data logging. - English as a first language, due to the speech testing material Exclusion Criteria: - Under 45 years old - Asymmetrical, mixed or conductive hearing loss, - Recent history (<1 year) of otalgia, otitis externa, otitis media with effusion. - Current or recent (<12 months ago) exposure to ototoxic medication e.g. cisplatin (or other platinum-containing chemotherapy drugs) or amikacin (or other aminoglycoside antibiotics), as stable hearing thresholds are required for the duration of the study. - Poor hearing aid user with data logging <5 hours a day. - English as a foreign language, illiterate or unable to read due to poor eyesight. - Diagnosis of conditions such as muscular dystrophies or chronic fatigue syndrome that may cause tiring during testing. - Diagnosis of dementia or a neurological condition that would suggest poor cognitive function. - Identification of a significant cochlear dead region (< 3kHz) in one ear only. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Manchester University NHS Foundation Trust | Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust | University of Manchester |
United Kingdom,
Ellis RJ, Munro KJ. Benefit from, and acclimatization to, frequency compression hearing aids in experienced adult hearing-aid users. Int J Audiol. 2015 Jan;54(1):37-47. doi: 10.3109/14992027.2014.948217. Epub 2014 Dec 3. — View Citation
Glista D, Scollie S, Bagatto M, Seewald R, Parsa V, Johnson A. Evaluation of nonlinear frequency compression: clinical outcomes. Int J Audiol. 2009;48(9):632-44. doi: 10.1080/14992020902971349. — View Citation
Pepler A, Munro KJ, Lewis K, Kluk K. Prevalence of cochlear dead regions in new referrals and existing adult hearing aid users. Ear Hear. 2014 May-Jun;35(3):e99-e109. doi: 10.1097/AUD.0000000000000011. — View Citation
Salorio-Corbetto M, Baer T, Moore BC. Quality ratings of frequency-compressed speech by participants with extensive high-frequency dead regions in the cochlea. Int J Audiol. 2017 Feb;56(2):106-120. doi: 10.1080/14992027.2016.1234071. Epub 2016 Oct 11. Erratum in: Int J Audiol. 2017 Feb;56(2):144. — View Citation
Salorio-Corbetto M, Baer T, Moore BCJ. Comparison of Frequency Transposition and Frequency Compression for People With Extensive Dead Regions in the Cochlea. Trends Hear. 2019 Jan-Dec;23:2331216518822206. doi: 10.1177/2331216518822206. — View Citation
Salorio-Corbetto M, Baer T, Moore BCJ. Evaluation of a Frequency-Lowering Algorithm for Adults With High-Frequency Hearing Loss. Trends Hear. 2017 Jan-Dec;21:2331216517734455. doi: 10.1177/2331216517734455. — View Citation
Vinay, Moore BC. Prevalence of dead regions in subjects with sensorineural hearing loss. Ear Hear. 2007 Apr;28(2):231-41. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bamford-Kowal-Bench (BKB) English-language sentences | BKB is a standard sentence list comprised of three or four key words per sentence. The adaptive BKB sentence test requires the noise to be presented at 55 A- weighted decibels (dBA) and the speech level adapts depending on whether the participant repeats the sentence correctly or not. Participants will be given a score in dB which corresponds to the intensity level at which 71% of the sentences are correctly identified. One sentence list will each be administered when the noise is presented at 0°, +90° and -90° and an average overall score in dB will be calculated. The lower the score in dB, the better the participant has performed. | Six weeks following the programming of each of the two hearing aid setting. | |
Primary | Arthur Boothroyd (AB) word list | The AB word list aims to assess patient's speech discrimination ability, awarding one point for each phoneme repeated correctly in each word. Words will be presented from a loudspeaker at 65 decibels sound pressure level (dB SPL) in the absence of background noise. All words are monosyllabic and comprised of three phonemes, one mark is awarded for each correct phoneme (0,1,2,3). A single list contains ten words, giving a total of 30 phonemes per list. For each test session, three different word lists will be used and the number of phonemes correctly repeated will be recorded, allowing participant's scores out of 90 to be calculated. The greater the score, the better the performance. | Six weeks following the programming of each of the two hearing aid setting. | |
Primary | Auditory speech sounds evaluation (ASSE). | ASSE is a psychoacoustic test that directly assesses participant's ability to discriminate between different phonemes. ASSE discrimination is an oddity test aiming to assess supra threshold performance. At a level of 70dB SPL, following three to eight presentations of a single speech sound, a different speech sound will be played, and participants should respond to the 'odd one out'. If participants respond correctly to two out of three presentations, it can be concluded that the contrast between the background phoneme and the odd speech sound is well discriminated and this will be marked as correct. Seven pairs will be used that include both high and low frequency containing phonemes. Participants will be given a percentage score based on how many of the seven speech pairs they are successfully able to discriminate between. The higher the percentage, the better able the participant is to discriminate. | Six weeks following the programming of each of the two hearing aid setting. | |
Primary | The SSQ12 questionnaire. | A validated shortened version of the speech, spatial and qualities of hearing scale (SSQ) questionnaire. The questionnaire will be administered during sessions three and four to compare patient's experiences with NLFC and CP. This will be carried out in an interview style format to ensure participants understand the questions. Participant's scores out of 120 will be calculated and compared in the two conditions. The higher the score, the better the patient finds the hearing aids. | Six weeks following the programming of each of the two hearing aid setting. |
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