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

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Brief Title

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

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.

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.
    

Detailed Description

      Potential participants will be recruited from the audiology database at Manchester Foundation
      Trust. Those who meet the inclusion criteria will be sent a letter in the post accompanied by
      a participation information sheet to raise their awareness of the project. This criterion
      includes those aged 45 and over with a bilateral moderate to severe sensorineural hearing
      loss who wear two hearing aids. They must report to wear these for > 5 hours each day which,
      will then be confirmed by their hearing aid data logging. English must be their first
      language due to the test material that will be used.

      Patients will be provided with a participant information sheet, outlining what will happen in
      each of the four sessions and a consent form. This participant information pack will inform
      potential participants about how they may indicate their interest or contact the researchers
      for more information about what the study entails. The investigators will try and recruit 30
      participants in total to allow for attrition in the event of withdrawal or exclusion from the
      study. The researchers hope to find 24 (12 in each group) eligible participants who will be
      able to complete the study. The researchers anticipate recruitment will be done over one
      month and data collection over four. It is possible that participants may be excluded from
      the study once testing begins if asymmetrical DRs are found (present at frequencies < 3kHz in
      one ear only) or any otological symptoms arise that prevent participants from wearing their
      aids for >5 hours a day. The sample size was taken based on pragmatic ground and time
      constraints as this is a MSc project.

      Participants who provide written, informed consent will attend a reassessment appointment
      (session one) a fitting appointment (session two) and a follow up appointment (session
      three). These appointments are routinely offered to all patients who are beginning a new
      hearing aid pathway. Additionally, the researchers are asking participants to attend one
      further follow up appointment (session four). Each session will last between one and one and
      a half hours.

      Session One- A reassessment is routinely offered to patients every three years and involves;

        -  A brief medical history to identify potential ototoxic medication, any otological
           symptoms and factors which may impact patient's ability to manage hearing aids.

        -  Establishing the patient's hearing aid history to determine use and understand the
           patient's lifestyle.

        -  Otoscopy (where the clinician will look in the ears) and tympanometry (where the
           clinician will assess the ear drums).

        -  A pure tone audiogram (PTA) to determine the patient's hearing thresholds.

        -  If required, impressions of the ears will be taken for new earmoulds to be made.

      Additionally, a TEN test will be performed in session one to assess for DRs. The TEN test
      procedure is similar to that of a standard PTA but involves ipsilateral masking. This
      prevents signal tones from being detected at other regions of the cochlea that surround the
      DR. By preventing off-frequency/place listening, a DR can be detected. Based on findings from
      the TEN test, participants will be split into two groups; those with significant bilateral
      cochlear DRs < 3kHz (the DR group) and those without cochlear DRs or a DR > 4kHz (the no DR
      group). Those with unilateral DRs < 3kHz will be excluded.

      Session two- During session two, all participants will be familiarised with the test material
      that will be used in sessions three and four. The adaptive Bamford Kowal Bench (BKB)
      English-language sentences, the Arthur Boothroyd (AB) word list and auditory speech sounds
      evaluation (ASSE) are all routine speech tests readily available within our audiology
      department. These will be the speech tests used to measure performance with NLFC and with CP.
      All testing will take place in a soundproof booth. None of these intensities should be too
      loud for participants as they aim to replicate normal conversational levels. Following any
      complains of loudness discomfort, the dB SPL will be reduced, and this will be recorded. The
      questionnaire used will be The SSQ12, a validated shortened version of the speech, spatial
      and qualities of hearing scale (SSQ) questionnaire that asks participants about their
      listening experiences in various situations. The SSQ12 will be shown to participants in
      session two, so they are aware of the situations they should be monitoring whilst wearing
      their hearing aids.

      BKB sentences will be played in the presence of noise presented at 55 A- weighted decibels
      (dBA) and the speech level adapts depending on whether the participant repeats the sentence
      correctly, or not. If two or more key words are repeatedly correctly, the response is
      considered correct. Following two correct responses, the speech intensity will be decreased.
      Following one incorrect response, the intensity of the signal will be increased. Participants
      will be given a score in dB which corresponds to the intensity level at which 71% of the
      sentences are correctly identified. The speech signal will always be presented from the front
      (0° azimuth). The noise signal will be presented from the front, from the left (-90°
      azimuth), and from the right (90° azimuth). One sentence list will be administered for the
      noise presented at 0°, +90° and -90° and an average overall score in dB will be calculated.

      The AB word list will be performed in the absence of background noise. Words will be played
      from a loudspeaker at 65 decibels sound pressure level (dB SPL). The test material consists
      of ten words per list and each word is made of three phonemes. A point is awarded for each
      correct phoneme (0,1,2,3) and the average score from three lists will be calculated.

      Additionally, participants will complete a phoneme discrimination task, ASSE at a level of
      70dB SPL. They will be asked to discriminate between various phoneme pairs by a 'same/
      different' procedure. Following three to eight presentations of a single speech sound,
      another speech sound will be played e.g. V-Z. 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, and participants will be given a percentage score based on how many they are
      successfully able to discriminate between.

      Also, during session two, participants will be fitted with bilateral Phonak Auto hearing
      aids. These will be programmed to NAL-NL2 prescription targets following departmental
      protocol and British Society of Audiology (BSA) recommended procedures, which includes making
      real ear measurements (REMs). NLFC will be programmed into all participants hearing aids but
      will be deactivated in half of the participants from each group in a randomised manner. This
      will be generated for each group separately as there will be 12 participants in the 'DR
      group' and 12 in the 'no DR group'. Using an Excel formula, participants in each group will
      be placed in a random order in a list. The first six participants listed in each group will
      experience NLFC first. The remaining six participants listed in each group will experience CP
      first. Participants will be unaware of how their aids are programmed. NLFC in the 'no DR'
      group will be validated according to BSA recommended procedures. NLFC in the 'DR group' will
      be set based on where their dead region begins. This will be set at 0.75 times their
      individual edge frequency (0.75Fe). Any fine tuning requested by participants of the hearing
      aids will be permitted up to 7 days following fitting.

      Session three- Around six weeks after the first fitting, session three will take place. This
      will consist of testing participants with their hearing aids set to their first condition
      using the adaptive BKB sentence test, AB word list and ASSE, as outlined above. Participants
      will also complete the SSQ12 in an interview style format. Following this, the participant's
      hearing aid settings will be swapped to the opposite condition i.e. if NLFC was activated in
      session two, this will be disabled in session three and vice versa. Any fine tuning requested
      by participants of the hearing aids will be permitted up to 7 days following fitting.

      Session four- Around six weeks later, session four will take place. This will involve testing
      participants with their hearing aids set to their second condition using the same test
      material and completing the same questionnaire as in session three. Participants will then be
      given a choice of which setting they would like permanently or can decide to go away with
      both settings programmed into the hearing aids and decide at a later date.
    


Study Type

Interventional


Primary Outcome

Bamford-Kowal-Bench (BKB) English-language sentences


Condition

Sensorineural Hearing Loss, Bilateral

Intervention

Hearing aids programmed conventionally.

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

24

Start Date

November 2019

Completion Date

March 2020

Primary Completion Date

March 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

44 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 01612765050, [email protected]



Administrative Informations


NCT ID

NCT04145661

Organization ID

B00700


Responsible Party

Sponsor

Study Sponsor

Manchester University NHS Foundation Trust

Collaborators

 University of Manchester

Study Sponsor

, , 


Verification Date

October 2019