Speech Perception and High Cognitive Demand

NCT ID: NCT04997577

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-27
• Study Completion Date: 2027-12-31

Brief Summary

With advancing age, adults experience increasing speech understanding difficulties in challenging situations. Currently, speech-in-noise difficulties are rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. The goal of the "Speech Perception and High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm. In the present study neural (as measured by pupillometry and magnetoencephalography) and behavioral changes of speech-in-noise perception from pretest to posttest will be examined in older adults (age 65 - 85 years) assigned to one of three training groups: 1) Active Control Group: sessions of watching informational videos, 2) Auditory Training Group: sessions of auditory training listening to one of two speakers in everyday scenarios (e.g., driving directions) and needing to recall what one speaker said in the previous sentence, and 3) Auditory-cognitive training group: identical to the auditory training group, except participants will be asked to remember information from two previous sentences. Changes in speech-in-noise perception will be examined for the three groups of older adults and gains will be compared to a control group of young, normal hearing adults (18-30 years) that is not part of the clinical trial and will not undergo any training.

Detailed Description

With advancing age, adults experience increasing difficulties in understanding speech in challenging situations, such as difficulty with understanding others in a noisy restaurant. Speech-in-noise difficulties are typically rehabilitated by providing hearing aids. For older normal-hearing adults, however, hearing devices do not provide much benefit since these adults do not have decreased hearing sensitivity. For these adults, communication difficulties persist in everyday life situations and can even lead to social withdrawal, isolation, and depression. A growing body of studies demonstrates that combined auditory-cognitive training paradigms can offer speech-in-noise benefits to adults with hearing loss that could prevent the consequences listed above.

The goal of the "Speech Perception with High Cognitive Demand" project is to evaluate the benefit of a new auditory-cognitive training paradigm for older normal-hearing adults. The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. Although it cannot ensure that every participant will experience direct significant benefit from the training, the paradigm is being designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level and to make the task challenging. In a separate training condition, a short-term memory component is added to the original training paradigm to also enhance the cognitive skills of the participants. In addition, the training is implemented on touch-screen laptops, making at-home training possible. This way, training is provided in a realistic setting which will ensure a better transfer of the trained skills to daily communication situations. The trial consists of three conditions: 1) Auditory only training, 2) Auditory-cognitive training, and 3) Active control of informational videos.

Conditions

Speech Intelligibility; Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Auditory training paradigm

Participants perform speech-in-noise perception tasks with real-world scenarios.

Group Type: EXPERIMENTAL

Auditory training paradigm

Intervention Type: BEHAVIORAL

The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.

Auditory-cognitive training paradigm

Participants perform speech-in-noise perception tasks with real-world scenarios. A short-term memory component is added to the training paradigm to make the task more engaging and challenging.

Group Type: EXPERIMENTAL

Auditory-cognitive training paradigm

Intervention Type: BEHAVIORAL

The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. A short-term memory component, in which listeners are asked to remember what a designated speaker said two sentences prior, was added to the auditory training paradigm to make the task more challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.

Interventions

Auditory-cognitive training paradigm

The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. A short-term memory component, in which listeners are asked to remember what a designated speaker said two sentences prior, was added to the auditory training paradigm to make the task more challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.

Intervention Type: BEHAVIORAL

Auditory training paradigm

The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged between 65 - 85 years
• Normal hearing (pure tone thresholds ≤ 25 dB HL from 250 - 8000 Hz)
• Self-reported normal or corrected-to-normal vision
• Dominant language: American English
• Education: a high school diploma or higher education level

Exclusion Criteria

• Middle-ear or inner-ear pathology
• Non-native speaker of English
• Inability to complete all training sessions within a pre-specified time window (e.g., due to unexpected schedule restrictions)
• Learning disorders
• Metal in body that induces a data artifact for MEG recording (e.g., excessive metal dental work) or that poses a safety issue in the MRI portion (e.g., pacemakers, neural implants, metal plates or joints, shrapnel, and surgical staples)
• Claustrophobia or any condition that would be exacerbated by the scanning environment's lighting, sounds, etc. (e.g., migraines)
• A non-removable hairstyle or hair accessory that would prevent the participant from fitting comfortably in the MEG or MRI head coil
• Currently under a medical provider's care for a closed head injury
• Currently taking psychoactive stimulant (e.g., amphetamines), depressant (e.g., benzodiazepines), mood stabilizing (e.g., lithium), anti-psychotic, or anti-seizure medications or drugs of abuse
• Currently pregnant (only for MRI)

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Maryland, College Park

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Simon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samira B Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Jonathan Z Simon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, College Park

Stefanie E Kuchinsky, PhD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Locations

Department of Hearing and Speech Sciences

College Park, Maryland, United States

Site Status: RECRUITING

Maryland Neuroimaging Center

College Park, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Z Simon, PhD

Role: CONTACT

jzsimon@umd.edu

301-405-3645

Michael A Johns, PhD

Role: CONTACT

maj@umd.edu

301-405-9604

Facility Contacts

Samira B Anderson, PhD

Role: primary

Sandy Collier

Role: primary

Stefanie Kuchinsky, PhD

Role: backup

References

Ferguson MA, Henshaw H. Auditory training can improve working memory, attention, and communication in adverse conditions for adults with hearing loss. Front Psychol. 2015 May 28;6:556. doi: 10.3389/fpsyg.2015.00556. eCollection 2015.

Reference Type: BACKGROUND

PMID: 26074826 (View on PubMed)

Lawrence BJ, Jayakody DMP, Henshaw H, Ferguson MA, Eikelboom RH, Loftus AM, Friedland PL. Auditory and Cognitive Training for Cognition in Adults With Hearing Loss: A Systematic Review and Meta-Analysis. Trends Hear. 2018 Jan-Dec;22:2331216518792096. doi: 10.1177/2331216518792096.

Reference Type: BACKGROUND

PMID: 30092719 (View on PubMed)

Other Identifiers

5P01AG055365-04

Identifier Type: NIH

Identifier Source: secondary_id

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P01AG055365

Identifier Type: NIH

Identifier Source: org_study_id

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