Non-linear Frequency Compared to Conventional Processing in Patients With and Without Cochlear Dead Regions.

NCT04145661 | Completed

• 1 other identifier: B00700
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sensorineural Hearing Loss, Bilateral; Cochlear Hearing Loss

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

DR group

EXPERIMENTAL

Participants who have cochlear dead regions, identified by the thresholds equalising noise test will be placed in this group.

Device: Hearing aids programmed conventionally.; Device: Hearing aids programmed with compression activated.

No DR group

EXPERIMENTAL

Participants who have no cochlear dead regions, identified by the thresholds equalising noise test will be placed in this group.

Device: Hearing aids programmed conventionally.; Device: Hearing aids programmed with compression activated.

Interventions

Hearing aids programmed conventionally. DEVICE

All participants will wear their hearing aids programmed in this way for around six weeks.

DR group; No DR group

Hearing aids programmed with compression activated. DEVICE

All participants will wear their hearing aids programmed in this way for around six weeks.

DR group; No DR group

Eligibility Criteria

• Age: 44 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead
• University of Manchester: collaborator

Study Sites (1)

Manchester University NHS Foundation Trust

Manchester, M13 9WU, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 30803386 BACKGROUND

• Vinay, Moore BC. Prevalence of dead regions in subjects with sensorineural hearing loss. Ear Hear. 2007 Apr;28(2):231-41. doi: 10.1097/AUD.0b013e31803126e2.

  PMID: 17496673 BACKGROUND

• 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.

  PMID: 27724057 BACKGROUND

• 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.

  PMID: 29027511 BACKGROUND

• 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.

  PMID: 24496291 BACKGROUND

• 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.

  PMID: 19504379 BACKGROUND

• 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.

  PMID: 25470620 BACKGROUND

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melissa Handford

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be aware of the type of hearing aid setting they are experiencing. All participants will experience both .
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be split into two groups depending on whether or not they have 'cochlear dead regions'. All participants will experience both conventional processing and frequency compression for six weeks. The order of which will be randomised and counterbalanced between groups.

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 30, 2019
• Study Start: November 20, 2019
• Primary Completion: March 26, 2020
• Study Completion: March 26, 2020
• Last Updated: June 1, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)