Clinical trial NCT04997577: Speech Perception and High Cognitive Demand
Official title: Auditory-cognitive Training Paradigm (NIH P01 Project - Speech Perception With High Cognitive Demand)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Speech Intelligibility
Aging
Keywords: Auditory-cognitive training
Aging
Speech-in-noise perception
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in speech-in-noise perception
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Audiobook - Change in pupillary response
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Audiobook - Change in magnetoencephalography (MEG) temporal response function
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Change in Magnetoencephalography (MEG) stimulus reconstruction accuracies and integration window analysis
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Audiobook - Change in frequency following response (FFR)
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Audiobook - Change in Magnetoencephalography (MEG) network localized granger causality
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
Secondary outcomes:
measure: Audiobook - Change in subjective ratings
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Tone cloud - Change in auditory stream segregation accuracy
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Tone cloud - Change in auditory stream segregation reaction time (RT)
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: N-back task - Change in accuracy
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: N-back task - Change in response time (RT)
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
measure: Reading Span (RSpan) - Change in working memory (WM)
timeFrame: Week 1-2 (pretest) and Week 5-6 (posttest)
Other outcomes:
Locations:
city: College Park
country: United States
facility: Department of Hearing and Speech Sciences
state: Maryland
city: College Park
country: United States
facility: Maryland Neuroimaging Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Samira B Anderson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland, College Park
name: Jonathan Z Simon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center
name: Stefanie E Kuchinsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.