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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04242940
Other study ID # BC103
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 21, 2020
Est. completion date May 17, 2022

Study information

Verified date September 2022
Source Oticon Medical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess listening effort during a speech-in-noise task in bone-anchored hearing systems (BAHS) users via pupillometry.


Description:

Pupil dilation can be used as an objective indicator of listening effort during the execution of a task. The aim is to compare listening effort with different settings (OpenSound Navigator ON and OFF) of Ponto 4, the sound processor released by Oticon Medical AB in June 2019, in listening scenarios that differ in complexity. The study consists of three visits of about two hours each in duration, during which the patients will perform a speech-in-noise task where the listening task varies in difficulty (i.e., in terms of signal-to-noise ratio, SNR). Pupil dilation will be recorded during the listening task as an indicator of listening effort. The patients will also use Ponto 4, instead of their own Ponto device, during a field-trial period of three months in between visit 2 and 3. Subjective evaluations of Ponto 4 will be performed via three questionnaires, one regarding self-reported performance in everyday life, one regarding work-related fatigue, and one regarding overall sound processor preference (Ponto 4 vs. patient's own device). All these outcome measures are non-invasive measurements. This is a post market study and all products used are CE marked and used in clinical practice worldwide.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date May 17, 2022
Est. primary completion date May 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Minimum 18 years and maximum 70 years old. - UK English mother tongue. - Bilateral conductive or mixed hearing loss. - Users fitted unilaterally or bilaterally on abutment. - Users are currently fitted with either Ponto 3, Ponto Plus or Ponto Pro (devices with a fitting range up to 45 dB HL). - Users with at least 6 months of daily experience with one Ponto sound processor. - BC thresholds of the implanted ear(s) better (lower) than or equal to 40 dB HL (average of 0.5, 1, 2 and 3 kHz) based on BC in-situ measurement at the first visit. - People currently employed/self-employed (since the Need for Recovery questionnaire refers to work-related fatigue). - Speech recognition scores better (higher) than or equal to 50% at +4 dB SNR with OSN OFF (as assessed via the first training list at Visit 1). This is to avoid including patients that are already "giving up" at +4 dB SNR. - Users entitled for a sound-processor upgrade (according to the investigator) will first be selected. If there are not enough users entitled for an upgrade, then patients fitted with Ponto between 7 and 12 months before visit 1 will be considered. If there are not enough users within 7-12 months, then patients fitted with Ponto between 13 and 18 months before visit 1 will be considered. Exclusion Criteria: - Single-sided deafness (SSD) - Hearing aid or cochlear implant on the opposite ear. - Test persons with current eye diseases and/or history of eye surgery on both eyes. - If the patient takes medications that can impact the autonomic nervous system - and hence pupil dilation (e.g., drugs for Parkinson's disease, peptic ulcers, incontinence, motion sickness). - If the investigator or physician assesses that the patient is not fit for trial participation.

Study Design


Intervention

Device:
Fitting of Ponto 4
Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting one/two bone-anchored sound processors (Ponto 4) to patients that are already implanted with abutments.

Locations

Country Name City State
United Kingdom Audiology Department, Nuffield House, University Hospitals Birmingham Birmingham West Midlands

Sponsors (1)

Lead Sponsor Collaborator
Oticon Medical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other Need for Recovery (NFR) questionnaire scores. Self-reported work-related fatigue. The NFR scale is an 11-item scale assessing the effects of fatigue caused by work (e.g., " I find it hard to relax at the end of a working day"). Possible responses are "yes" or "no". The total NFR score is the number of "yes" responses divided by the total number of items, presented as a percentage (i.e., range 0-100). The higher the score, the greater the NfR felt by the respondent. 4 months
Other Pupil dilation after field trial. Change in pupil dilation after field trial to check for acclimatization effects. 4 months
Primary Overall pupil dilation Overall pupil dilation for OSN ON and OSN OFF at +4 dB SNR 10 days
Secondary Peak and overall pupil dilation Pupil dilation at different SNRs 10 days
Secondary Growth Curve Analysis parameters. GCA at different SNRs 10 days
Secondary Speech recognition scores Performance (% correct) at different SNRs 10 days
Secondary Speech Spatial and Qualities of Hearing scale (SSQ) questionnaire scores Self-reported perception before, during, and after field trial. The SSQ questionnaire consists of 49 items with a scale from 0-10 where 0 represents "Not at all" and 10 represents "Perfect". 4 months
Secondary Preference questionnaire scores. Self-reported preference after field trial. The preference questionnaire consists of 11 questions. The scores are from 1 to 5, where 1 means "Own sound processor much better" and 5 means "Test sound processor much better". 4 months
Secondary Aided sound field thresholds Sound field audiometry performed with the Auricle system while the patient is wearing the Ponto sound processor. This measurement is conducted at 10 frequencies from 250 Hz to 8 kHz. 4 months
Secondary BC in situ thresholds. Hearing level thresholds (dB HL) as assessed in situ with Ponto 4 placed on the patient's abutment. Bone-conduction thresholds (BC) are measured as the softest sound level that is audible by the patient at 10 frequencies from 250 Hz to 8 kHz. 1 hour
See also
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Active, not recruiting NCT00763243 - Pilot Study of the Feasibility and Efficacy of Working Memory Training in Children With Cochlear Implants N/A