NCT05584514

Brief Summary

Sensorineural hearing loss (SNHL) is among the most prevalent chronic conditions in aging and has a profoundly negative effect on speech comprehension, leading to increased social isolation, reduced quality of life, and increased risk for the development of dementia in older adulthood. Typical audiological tests and interventions, which focus on measuring and restoring audibility, do not explain the full range of cognitive difficulties that adults with hearing loss experience in speech comprehension. For example, adults with SNHL have to work disproportionally harder to decode acoustically degraded speech. That additional effort is thought to diminish shared executive and attentional resources for higher-level language processes, impacting subsequent comprehension and memory, even when speech is completely intelligible. This phenomenon has been referred to as listening effort (LE). There is a growing understanding that these cognitive factors are a critical and often "hidden effect" of hearing loss. At the same time, the effects of LE on the neural mechanisms of language processing and memory in SNHL are currently not well understood. In order to develop evidence-based assessments and interventions to improve comprehension and memory in SNHL, it is critical that we elucidate the cognitive and neural mechanisms of LE and its consequences for speech comprehension. In this project, we adopt a multi-method approach, combining methods from clinical audiology, psycholinguistics, and cognitive neuroscience to address this gap of knowledge. Specifically, we adopt a novel and innovative method of co-registering pupillometry (a reliable physiological measure of LE) and language-related event-related brain potential (ERP) measures during real-time speech processing to characterize the effects of acoustic challenge and LE on high-level language processes (e.g., semantic retrieval, syntactic integration) and subsequent speech memory in older adults with SNHL. This innovative work addresses a time-sensitive gap in the literature regarding the identification of objective and reliable markers of specific neurocognitive processes impacted by acoustic challenge and LE in age-related SNHL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 18, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

October 13, 2022

Last Update Submit

November 15, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • N400

    The N400 mean amplitude and latency will be measured from the ERP waveform for each condition, using standard procedures for ERP research.

    1 day

  • P600

    The P600 mean amplitude and latency will be measured from the ERP waveform for each condition, using standard procedures.

    1 day

  • Pupil Dilation

    The pupil dilation response (average proportion change from baseline) will be measured from the continuous pupillometry time series, measured prior to target word onset, and compared between speech samples presented in quiet and in noise.

    1 day

  • Delayed Recognition Memory

    Recognition memory will be measured using both standard accuracy and signal detection measures from the recognition memory task

    1 day

Study Arms (1)

Arm 1

EXPERIMENTAL

The study is a within-subjects 2 x 3 factorial design. All participants are exposed to all experimental conditions or "interventions"

Other: Sentence StimulusOther: Auditory Noise

Interventions

The sentences are designed such that a specific target word is either (a) Plausible (normal), (b) a semantic pragmatic violation, or (c) a morpho-syntactic violation. Example: e.g., "Every morning at breakfast, the boys would (A: EAT)/ (B.PLANT )/ (C. EATS ) eggs..."

Arm 1

The sentences will be presented either A) in quiet, or B) with speech- shaped stationary background noise presented 3dB below the speech.

Arm 1

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 60-90; right-handed; native English speaker; scores in the normal range (\< 25 points) on Montreal Cognitive Assessment (MoCA); for adults with hearing loss, a pure-tone average score of \> 25 dB HL (between 1 - 4kHz)

You may not qualify if:

  • left-handed (language-related electrophysiological responses of left-handed subjects differ from those of right-handed subjects); history of psychiatric or neurological illnesses (including skull fractures, as this is known to alter electrophysiological response at the scalp); score of \> 25 points on the MOCA; use of certain prescription and non-prescription drugs known to alter brain function and the autonomic nervous system, including pupil dilation (e.g., anti-depressants, ADHD drugs); any eye disease that would impair the ability to measure pupil dilation (e.g., cataracts, nystagmus, amblyopia); scores on speech shadowing audibility control task below 50%, suggesting poor intelligibility; a display of behavior that would significantly interfere with the validity of data collection or safety during the study;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84101, United States

Location

Study Officials

  • Brennan R Payne, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No masking -- participants are presented various stimuli in different experimental conditions.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: This basic science experiment meets the NIH criteria of a BESH (Basic Experimental Study with Humans) Trial. All participants are exposed to all experimental conditions (i.e., "interventions") in a complete factorial 2 x 3 within-subjects experimental design. "Interventions" involve presenting various speech stimuli to participants.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

October 13, 2022

First Posted

October 18, 2022

Study Start

January 1, 2022

Primary Completion

August 30, 2023

Study Completion

August 30, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

All experimental code and associated stimuli will be posted online. Experimental protocols, analysis plans, and materials will be made publically available via the Center for Open Science: Open Science Framework (osf.io). Once core findings are published, we will make all de-identified data available to the scientific community via OSF as well. This will include raw data, along with a README documentation detailing the meaning of the columns used to store the data. Format of the data will be under the form of general .txt or .csv, and .ascii (alpha- numeric character) documents suitable for reanalysis. This data set will contain no personally identifying information, and the website will be linked from our respective laboratory webpages and posted in all publications.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will be available upon completion of the first manuscript from this paper, with an anticipated date of one year from end of study.
Access Criteria
Open access

Locations