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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Auditory speech sounds evaluation (ASSE).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will not be aware of the type of hearing aid setting they are experiencing. All participants will experience both .
入排标准
- 年龄范围
- 44 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Auditory speech sounds evaluation (ASSE).
时间窗: Six weeks following the programming of each of the two hearing aid setting.
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.
Bamford-Kowal-Bench (BKB) English-language sentences
时间窗: Six weeks following the programming of each of the two hearing aid setting.
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.
Arthur Boothroyd (AB) word list
时间窗: Six weeks following the programming of each of the two hearing aid setting.
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.
The SSQ12 questionnaire.
时间窗: Six weeks following the programming of each of the two hearing aid setting.
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.
次要结局
未报告次要终点