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SpeechNCT06053190

Effects of Clear Speech on Listening Effort and Memory in Sentence Processing

A study testing Sentence stimulus and Speaking style in people with Speech and Memory, Delayed, run by University of Utah at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
What is being tested?
Sentence stimulus and Speaking style
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
12 Sep 2023to 1 Mar 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 60-90
  • Right-handed
  • Native English speaker
  • Scores in the normal range (> or = 25 points) on Montreal Cognitive Assessment (MoCA)
  • For adults with hearing loss, a pure-tone average score of > 25 dB HL (between 1 - 4kHz)

Who cannot join

  • 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, attention deficit hyperactivity disorder 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • University of Utah

    Salt Lake City, Utah, 84109

    Brennan R Payne, PhD, brennan.payne@psych.utah.edu

    Recruiting

Other trials in United States

About this study

Official title: Understanding the Effects of Listening Effort on Sentence Processing and Memory in Sensorineural Hearing Loss: Evidence From Simultaneous Electrophysiology and Pupillometry (Study 2)

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 the cognitive and neural mechanisms of LE and its consequences for speech comprehension are elucidated. In this project, the investigators adopt a multi-method approach, combining methods from clinical audiology, psycholinguistics, and cognitive neuroscience to address this gap of knowledge. Specifically, the investigators 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 clear speech (i.e., a listener-oriented speaking style that is spontaneously adopted to improve intelligibility when speakers are aware of a perception difficulty on behalf of the listener) 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 speech clarity and LE in age-related SNHL.

Read the detailed description

This experiment is a Basic Experimental Study with Humans (BESH) Trial. All participants are exposed to all experimental conditions (i.e., "interventions") in a complete factorial 2 x 3 within-subjects experimental design. Participants will consist of 80 older adults between the ages of 60 - 90 who will be recruited from the Salt Lake metro community. Participants will be recruited through the Utah Senior Ears database, the Utah Center on Aging, through flyers placed throughout the community (e.g., bulletin boards, waiting area in the Ear Nose and Throat (ENT) clinic at the University of Utah), through on-line advertisements (e.g., Facebook) and via word-of-mouth. The investigators will recruit for an approximately equal number of participants into two hearing groups based on their pure-tone average (PTA) thresholds: normal hearing (PTA of < 25 decibels hearing level (dB HL), 1-4kHz) and clinically-relevant hearing loss (PTA of > 25 dBHL 1-4kHz). While this dichotomous grouping for recruitment is adopted, hearing level will be treated as continuous to increase statistical power.

The investigators will follow all American Psychological Association (APA) guidelines with respect to the treatment of human subjects. All participants will provide informed consent after study procedures are explained to them and the voluntary nature of participation will be emphasized. No identifying information (e.g., names) will be obtained from participants and the only information connected to their data files will be a unique, arbitrary code.

Study procedures will be conducted within a single session, lasting between 3-4 hours. Following informed consent, participants will complete a standardized hearing assessment, neuropsychological assessment, audibility control assessment, and then participant in the EEG/pupillometry experiment, each of which is described below. All data will be stored on password-protected computers in the PI's laboratory. All material from participants will be collected specifically for research purposes. The materials presented in these studies have no known potential to stress, embarrass, stigmatize, or incriminate experimental participants.

Prior to the beginning of the experiment, the investigators will conduct two audiometric tests via a Maico MA-41 audiometer via RadioEar IP-30 insert air-conduction earphones. First, pure-tone thresholds will be measured using the modified Hughson- Westlake at octave frequencies from 250 to 8000 Hz for each ear. Second, the investigators will test speech recognition thresholds (SRTs) using a recorded Central Institute for the Deaf (CID) W-1 spondee word list Near visual acuity was also tested for both the right and left eye using the Rosenbaum visual acuity test.

Participants will then complete a brief battery of cognitive assessments. (a) the Montreal Cognitive Assessment (MoCA). Although the appropriate cut-off score for cognitive impairment in the MoCA is variable across samples, individuals scoring below 20 are generally considered to be at increased risk for mild cognitive impairment (MCI). Therefore, the investigators use this as our conservative cut-off. Participants will also complete the F-A-S phonemic fluency task as a measure of verbal fluency, via the short- form computerized version of the reading span task as a measure of verbal working memory, and the extended range vocabulary tests from the Educational Testing Services Kit of Factor Referenced Cognitive Tests, as a measure of verbal ability. Participants will then complete an audibility control task. For this task, the same native speaker of American English will be used to record the stimuli at the same +3dB. Participants will hear nine different test sentences (e.g., "Don't touch the wet paint) and will be tasked with "shadowing" each sentence by repeating out loud each word as it was heard. The immediate repetition is done to reduce the contribution of any memory components to task performance.

Following the audiological and neuropsychological testing, the investigators will begin the primary experiment. Electrophysiological data (EEG), pupil dilation measurements (pupillometry), and behavioral recordings will be made from participants. EEG will be recorded from 64 silver-silver chloride electrodes embedded in an EasyCap (Electro-Cap, Inc), following a 10-20 montage. In addition, an electrode will placed on the left infraorbital ridge to monitor for vertical eye movements and blinks, and a virtual bipolar horizontal electrooculogram channel will be created offline for monitoring horizontal eye movements by calculating a difference between two fronto-temporal electrodes FT10-FT9 that sit posterior to the outer canthus of each eye. The continuous EEG will be amplified with a BrainAmp DC amplifier (Brain-Vision, LLC, Morrisville, NC) (bandwidth filtered: 0.02-250 Hz) and recorded to hard disk at a sampling rate of 1000 Hz. Electrode impedances will be kept below 5 kOhms. During the listening task, pupil size measurements will be continuously recorded from the right eye using an Eyelink 1000 Plus desktop mounted infrared eye tracker camera distributed by SR Research (SR Research Ltd., Ottawa, ON, Canada). Continuous pupil size measurements will be recorded at a rate of 1000 Hz using Eyelink software and will be downsampled offline to 50 Hz. See Statistical Analysis and Power for information on pupil data processing and cleaning.

Participants will be tested in a quiet sound-attenuated testing room. Participants will be seated 85 cm from a 24-in high-performance LCD monitor that will be used to present instructions and cues to the participant (e.g., when to take a break). Speech stimuli will be presented through the sound card of the stimulus presentation computer and routed to a Maico MA-41 audiometer via the auxiliary channel, allowing for direct control of stimulus intensity. The audiometer will route the speech to the participant via RadioEar IP-30 insert air-conduction earphones. Stimuli will be presented presented at 65 dB HL for all participants to their better hearing ear (based on PTA thresholds between 1-4 kHz). All hardware is calibrated to standard in our testing room by a certified technician.

The experiment will be programmed in Python via the PsychoPy open source platform. There will be 360 trials. On each trial, participants will listen to a sentence that contains a single target word that will either be a normal plausible continuation, a semantic violation, or a syntactic violation (see Table 1 in Research Plan). In addition, speech will be produced either using a conversational speaking style or a hyperarticulated clear speech speaking style (see Research Plan for more information), in a 2 x 3 within-subjects factorial design. Clear and conversational speech samples will be elicited from a single male talker. In the conversational speech condition, which will be recorded first, the talker will be instructed to read the sentences as they would in everyday conversation. In the clear speech condition, the talker will be instructed to produce the sentences as if they would if they were talking to a person with hearing loss . Stimuli will be counterbalanced across experimental conditions following a Latin square design, with each participant randomized to one of six experimental presentation lists. This ensures that each critical word appears equally often across experimental conditions and that no participants will see the same critical word or sentence more than once.

All sentences will be presented in +3 decibel (dB) signal-to-noise ratio (SNR) stationary speech-shaped background noise in induce acoustic challenge. EEG will be measured continuously during speech processing.

After the end of the 360 sentences, a delayed recognition memory task will be administered. Participants will be visually presented with 360 test sentence frames on a tablet computer, each with the target word missing. They will be instructed to mark whether or not they recognized each sentence as one that they had heard during the experimental task. For the sentences they reported as having heard previously, they will be asked to recall the target word to the best of their ability by typing their response. There will be no time limit on the memory test. 180 of the sentences will be old items that they had heard during the task and the other 180 will be semantic foils. The 180 sentences that were ones heard previously will be taken evenly from each of the six experimental conditions, such that there will be 30 sentences from each condition. Each semantic foil will be created by taking 2 to 4 of the meaning-bearing words from a sentence that the participant had actually heard and these will be used to create a new semantically similar sentence. For example, if the participant had heard the sentence "Dan recognized John even though he had grown a beard since the last time they saw each other.", a semantic foil may be: "No one at the reunion recognized Dan because he had grown a _____ since the last time everyone met." The inclusion of foils are used to make the recognition task more challenging in order to reduce the likelihood of ceiling performance. This approach has been validated in past studies on listening effort and recognition memory. Although the primary memory analyses concern sentence recognition memory, the investigators will also report performance on the cued word recall task as well, as the investigators have done in prior work.

Upon completion of the memory assessment, the study procedures will be complete. Participants will be debriefed and will have the opportunity to ask any questions of the study team.

Being tested
Sentence stimulus, Speaking style
Medical subject headings
Speech, Hearing Loss, Sensorineural

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sentence stimulusBehavioural

    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..."

  • Speaking styleBehavioural

    The sentences will be presented either in A. conversational speaking style, or B. hyper-articulated clear speech style. Clear and conversational speech samples will be elicited from a single male talker. In the conversational speech condition, which will be recorded first, the talker will be instructed to read the sentences as they would in everyday conversation. In the clear speech condition, the talker will be instructed to produce the sentences as if they would if they were talking to a person with hearing loss.

Study groups in NCT06053190
Study groupRoleWhat they receive
Speech StudyExperimentalThe study is a within-subjects 2 x 3 factorial design. All participants are exposed to all experimental conditions or "interventions"
Receives: Behavioral: Sentence stimulus; Behavioral: Speaking style

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. N400 amplitude

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

    Measured: During the speech listening portion of the experiment, up to 4 hours.

  2. N400 latency

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

    Measured: During the speech listening portion of the experiment, up to 4 hours.

  3. P600 amplitude

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

    Measured: During the speech listening portion of the experiment, up to 4 hours.

  4. P600 latency

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

    Measured: During the speech listening portion of the experiment, up to 4 hours.

  5. 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 clear and conversational speech.

    Measured: During the speech listening portion of the experiment, up to 4 hours.

  6. Delayed Recognition Memory

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

    Measured: Immediately after the speech listening portion of the experiment, up to 30 minutes.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start12 Sep 2023
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053190
Sponsor's protocol ID
00145808b
Status last verified
Jan 2025
First submitted
17 Aug 2023
Last updated
13 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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, the investigators will make all de-identified data available to the scientific community via Open Science Framework (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.

Questions about this trial

What is this clinical trial studying?

A study testing Sentence stimulus and Speaking style in people with Speech and Memory, Delayed, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brennan R Payne (801-581-5040, brennan.payne@psych.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

N400 amplitude (time frame: During the speech listening portion of the experiment, up to 4 hours.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.

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