Clinical trial NCT04242940: Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users
Official title: Assessing Listening Effort at Different Signal-to-noise Ratios in Bone-anchored Users
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bilateral Hearing Loss
Keywords: Bone anchored hearing systems
BAHS
Listening effort
Pupillometry
Ponto 4
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Pupil Dilation
timeFrame: 10 days
Secondary outcomes:
measure: Peak Pupil Dilation (PPD) for OSN ON and OSN OFF
timeFrame: 10 days
measure: Speech Recognition Scores With OSN ON vs. OSN OFF Across SNRs
timeFrame: 10 days
measure: Speech Spatial and Qualities of Hearing Scale (SSQ) Questionnaire Scores
timeFrame: 4 months
measure: Preference Questionnaire Scores.
timeFrame: 4 months
measure: Aided Sound Field Thresholds
timeFrame: 4 months
measure: BC in Situ Thresholds.
timeFrame: 1 hour
Other outcomes:
measure: Need for Recovery (NFR) Questionnaire Scores.
timeFrame: 4 months
measure: Pupil Dilation After Field Trial.
timeFrame: 4 months
Locations:
city: Birmingham
country: United Kingdom
facility: Audiology Department, Nuffield House, University Hospitals Birmingham
state: West Midlands
Study officials:
affiliation: University Hospitals Birmingham, United Kingdom
name: William Brassington
role: PRINCIPAL_INVESTIGATOR
References: