- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05901493
Category Learning Retention in Adults With and Without Developmental Language Disorder (Time2Learn)
March 8, 2024 updated by: University of Delaware
Improving the Retention of Speech-Perceptual Learning in Adults With and Without Language Disorder
Approximately 7% of the population experiences developmental language disorder (DLD), a language disorder with unclear causes.
DLD affects communication beyond adolescence and poses challenges for education and career advancement due to difficulties in learning and memory.
Recent research suggests that adults with DLD struggle with overnight memory consolidation, indicating a need for effective learning and memory support.
This project aims to determine the optimal training schedule for perceptual memory retention in adults with and without DLD.
The study involves recruiting 240 adults (120 with DLD, 120 without) for speech-perceptual training with different training schedules.
The researchers predict that the manipulation of training schedules will interact with circadian preference and overnight consolidation, leading to the discovery of the best practice schedule for speech sound retention.
Additionally, 300 more adults (150 with DLD, 150 without) will be recruited to investigate how optimal training schedules interact with reflexive and reflective learning strategies.
The time course of learning and retention will be tracked during reflexive and reflective categorization training in six different training schedules.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
Developmental language disorder (DLD) describes the idiopathic disorder(s) of language that occurs in approximately 7% of the population.
Although DLD is understudied in adulthood, it is clear that the communication challenges in DLD extend beyond adolescence.
The barriers to educational and vocational achievement for adults with DLD include persistent difficulties in learning and memory.
Recent work suggests that these difficulties with learning and memory include deficits in overnight memory consolidation.
Thus, an effective support for learning and memory function in adults with DLD must include strategies for both overcoming initial challenges in learning, as well as in mitigating a deficit in consolidation of learned information.
In this project, the investigators combine insights from the neurobiology of learning and memory, chronobiology, and speech perception, to determine the optimal training schedule for perceptual memory retention in adults with and without DLD.
The investigators have two Aims in this project: First, the investigators will recruit 240 adults (120 with/120 without DLD) to participate in a speech-perceptual training to take place in one of six different training schedules over 24 hours.
The investigators predict that our manipulation of training schedules will interact with circadian preference and timing relative to overnight consolidation, to allow the discovery of the optimal practice schedule for speech sound retention for adult learners with & without DLD.
Under our second aim, the investigators will recruit an additional 300 adults (150 with/150 without DLD) in order to determine how optimal training schedules interact with reflexive and reflective learning strategies in adults with and without DLD.
The investigators will achieve this aim by tracking the time course of learning and retention in adults participating in reflexive and reflective categorization training in one of six training schedules.
Study Type
Interventional
Enrollment (Estimated)
540
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Frances Earle, PhD
- Phone Number: 6468128376
- Email: fsearle@udel.edu
Study Locations
-
-
Delaware
-
Newark, Delaware, United States, 19713
- Recruiting
- University of Delaware
-
Contact:
- Frances S Earle, PhD
- Phone Number: 302-831-3878
- Email: fsearle@udel.edu
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Recruiting
- Northeastern University
-
Contact:
- Zhenghan Qi, PhD
- Email: z.qi@northeastern.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- native speakers of American English
- Grew up in a household in which only American English was spoken
- 18-55 years of age
- Typical vision & hearing
- (Aim 2) access to headphones/devices capable of accessing experiment script via internet
- Must meet criteria for Group membership as either TD or DLD
Exclusion Criteria:
- History of neurological disorders
- History of psychiatric disorders
- History of socio-emotional disorders
- On prescription medication(s) that alter sleep
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Blocked Evening Only Training
One hour training in the evening, followed by a one hour training 24 hours later
|
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
|
Experimental: Distributed Evening Training
One hour training in the evening, followed by a two 30 min trainings 12 and 24 hours later
|
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
|
Experimental: Blocked Evening-Morning Training
One hour training in the evening, followed by a one hour training 12 hours later
|
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
|
Experimental: Blocked Morning Only Training
One hour training in the morning, followed by a one hour training 24 hours later
|
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
|
Experimental: Distributed Morning Training
One hour training in the morning, followed by a two 30 min trainings 12 and 24 hours later
|
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
|
Experimental: Blocked Morning-Evening Training
One hour training in the morning, followed by a one hour training 12 hours later
|
Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech discrimination - behavior
Time Frame: 1 week
|
Participants will be administered a short (approximately 4-minute) behavioral task.
They will be exposed to two speech sounds, separated by a 1-second interval.
Some sounds will begin with the dental stop consonant, and other sounds will begin with the retroflex stop consonant.
Participants will be asked to decide if the two sounds they hear are the same or different.
Accuracy will be converted to d-prime (a measure of signal detection).
This d-prime score will be the primary behavioral outcome for speech discrimination.
|
1 week
|
category identification - behavior
Time Frame: 48 hours
|
Participants will be administered a short (approximately 2 minutes) for each modality (auditory and visual).
Participants will either hear (auditory - pure tone) or see (visual - gabor patch) a stimulus, and will need to choose which category the stimulus belongs to out of a choice of two.
The percentage of trials that are answered correctly will be the primary behavioral outcome for auditory and visual category identification.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Speech discrimination - Event-related potential of the electroencephalogram (ERP/EEG)
Time Frame: 1 event-related potential (ERP) session 1 week following training
|
The investigators will fit the participant's head with a pre-positioned electrode cap, with electrolytic gel applied between the electrodes and the scalp.
The participants will watch a silent movie while dental and retroflex speech tokens are presented in an oddball paradigm.
The investigators will record the participants' electroencephalogram (EEG) while the auditory stimuli are presented.
The EEG data will be segmented to examine the fluctuations in voltage recorded at the scalp (in milivolts) for a duration of one second after the onset of each stimulus.
The segmented data will be averaged across dental trials, and across the retroflex trials.
The resultant waveforms will be subtracted from one another.
The peak of the deflection in the difference waveform found approximately 250miliseconds following stimulus onset is the mismatch negativity (MMN) component.
The magnitude of the MMN component will be our primary outcome measure.
|
1 event-related potential (ERP) session 1 week following training
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 23, 2022
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
July 31, 2027
Study Registration Dates
First Submitted
May 19, 2023
First Submitted That Met QC Criteria
June 2, 2023
First Posted (Actual)
June 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1938428
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
de-identified data will be uploaded to the Open Science Framework alongside publications to stem from data from this project
IPD Sharing Time Frame
This data will be made available upon publication of the data, indefinitely
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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