Language Development DisordersNCT03609502
Perceptual Learning and Memory Consolidation in Adults With and Without LI
A study testing behavioral training in people with Language Development Disorders, run by University of Delaware at 1 site in United States.
Trial summary
This study tests a memory-based account of atypical speech perception in adults with language-based learning disability (also known as developmental language impairment [LI]). One perspective regarding the its etiology considers impoverished speech sound representations to be central to the linguistic symptoms… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Language Development Disorders
- What is being tested?
- behavioral training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Monolingual speakers of American English
- History of:
- Typical gestation
- Sensory-motor development
- Typical hearing and vision
- Nonverbal cognition within normal limits
Who cannot join
- Current diagnosis of ADHD
- Developmental dyslexia
- Rapid automatized naming deficits
- Neurological disorders
- Socio-emotional disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceptual Learning and Memory Consolidation in Adults With and Without Language Impairment
This study tests a memory-based account of atypical speech perception in adults with language-based learning disability (also known as developmental language impairment [LI]). One perspective regarding the its etiology considers impoverished speech sound representations to be central to the linguistic symptoms observed in LI. This project examines a potential abnormality in the process of building speech sound representations in LI.
Previous work by the PI has found that sleep is important for learning speech sounds. Furthermore, different measures of speech perception (identification and discrimination), reveal distinct patterns of learning that are consistent with that of declarative and procedural memory consolidation. A division of labor by declarative and procedural memory systems in the building of speech representations may imply that problems with phonology may stem from selective weaknesses in declarative or procedural memory in predictive ways.
Read more
The first project Aim is to identify the memory substrates of novel phonetic category formation. In Experiment 1, the investigators will obtain behavioral measures of declarative, procedural, and speech sound learning before and after post-training sleep in 40 typical adults and 20 adults with LI. Among typical adults, a double dissociation is predicted in which speech identification will be predicted by individual differences in declarative memory, and speech discrimination will be predicted by individual differences in procedural memory. Moreover, adults with LI are predicted to demonstrate consolidation deficits across memory types.
The second project Aim is to identify the neural substrates of phonetic category formation. In Experiment 2, the investigators will obtain functional magnetic resonance (fMRI) recordings of 20 TD and 20 LI adults performing post-training identification and discrimination tasks on a trained speech contrast before and after sleep. In typical adults, a Time by Speech-task interaction is predicted. Speech identification will recruit episodic (hippocampal) information on Day 1 relative to classic regions for phonological processing on Day 2. Speech discrimination will result in a change in magnitude of activation from Days 1 and 2 in the left inferior frontal gyrus (IFG), reflecting an overnight decrease in effort. LI (n=20) is predicted to demonstrate reduced overnight change in neural activation relative to TD in both tasks.
Read the detailed description
The investigators will recruit 60 adults with typical language (TD) and 40 LI participants through a variety of community and university related contacts. 40 TD adults and 20 LI participants will be enrolled in Experiment 1. 20 TD adults and 20 LI participants will be enrolled in Experiment 2.
Both experiments will take place over 3 Sessions.
During Session 1, the investigators will administer various measures in order to validate study eligibility, classify participants into groups, and other measures in order to further characterize our samples. To that end, participants will be administered a pure tone audiometric screening, and complete an interview questionnaire asking for background information such as handedness, language background, language and reading development, and development of motor skills. Trained research personnel will then administer an approximately 2-hour testing battery that includes measures of nonverbal cognition, language ability, reading ability, attention, executive function, and phonological processing. Participants will also complete questionnaires to assess their habitual sleep quality, sleepiness, and individual chronotpyes.
All testing will be completed by a student clinician, and will be supervised by a certified speech-language pathologist. 100% of administrations will be re-scored by a trained student for accuracy. To account for attrition and non-qualifiers, we anticipate enrolling/screening up to 200 individuals in Session 1 in order to arrive at the enrollment targets for Experiments 1 and 2.
In both experiments, Sessions 2 and 3 takes place on two consecutive days. Session 2 will take place in the late evening, and Session 3 will take place in the morning. We have intentionally chosen not to employ a wake-state (AM-PM) control. This is done in order to limit the potential variability in the amount of English exposure between sessions. Between-session sleep duration will be monitored with an Actigraph wGT3X-BT accelerometer (Actigraph, corp) worn on the non-dominant wrist. Actigraphs will be set to collect data in 60-second epochs via a validated algorithm (Cain \& Geremia,2011). This method of recording sleep/wake activity has been independently validated to agree with lab polysomnography at 85% accuracy (Slater et al.,2015).
Experiment 1: behavioral measures During Session 2, participants will complete the three learning tasks, declarative learning, procedural learning, nonnative speech learning (in that order), and immediate post-learning assessments. During Session 3, participants will be re-assessed in nonnative speech learning, declarative learning, and procedural learning (in that order).
- Declarative memory will be assessed using an object recognition task following incidental encoding.
- A version of the Serial Reaction Time task will be used to measure procedural learning.
- Perceptual learning of speech will be measured through performance on identification and discrimination tasks on the dental and retroflex contrast.
Experiment 2: neuroimaging measures During Session 2, participants will complete the nonnative contrast training in the late evening. Then they will enter a magnetic resonance imagine (MRI) scanner, where their blood oxygen-level dependent signals will be recorded while they complete the post-training identification and discrimination assessments. The participants will complete the same in-scanner assessments of the perception of the nonnative contrast during Session 3.
- Conditions
- Language Development Disorders
- Being tested
- behavioral training
- Keywords
- sleep, memory consolidation, speech perception
- Medical subject headings
- Language Development Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
behavioral trainingBehavioural
the participants will be trained to perceive a non-native speech contrast
| Study group | Role | What they receive |
|---|---|---|
| behavioral | Experimental | Adults with and without language impairment will be given three different types of behavioral training, and assessments of learning through those trainings, at two time points. Receives: Behavioral: behavioral training |
| neuroimaging | Experimental | Following speech sound behavioral training, adults with and without language impairment will undergo post-training perceptual assessments in an MRI scanner before and after post-training sleep. Receives: Behavioral: behavioral training |
What is being measured
The primary outcome is the main question the study is designed to answer.
nonnative speech sound learning: behavioral measures of memory consolidation
learning will be assessed via behavioral performance (accuracy transformed to d') on perceptual tasks before training, after training, and after a post-training period of sleep
Measured: 2 days
nonnative speech sound learning: fMRI measures of memory consolidation
change over a period of sleep in neural activation (BOLD response) in response to learned speech
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start1 Aug 2018
- Primary completion1 Mar 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Why it stopped: research facilities temporarily closed due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language Development DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a 2x2 mixed (Group by Time) design
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Sayako Earle, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609502
- Sponsor's protocol ID
- 1280021
- Status last verified
- Jul 2020
- First submitted
- 28 Jun 2018
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptual Learning and Memory Consolidation in Adults With and Without Language Impairment
- ClinicalTrials.gov ID
- NCT03609502
- Acronym / sponsor ID
- 1280021
- Conditions
- Language Development Disorders
- Keywords
- sleep, memory consolidation, speech perception
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: research facilities temporarily closed due to COVID-19
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 1 Mar 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 1 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tests a memory-based account of atypical speech perception in adults with language-based learning disability (also known as developmental language impairment [LI]). One perspective regarding the its etiology considers impoverished speech sound representations to be central to the linguistic symptoms observed in LI. This project examines a potential abnormality in the process of building speech sound representations in LI.
Previous work by the PI has found that sleep is important for learning speech sounds. Furthermore, different measures of speech perception (identification and discrimination), reveal distinct patterns of learning that are consistent with that of declarative and procedural memory consolidation. A division of labor by declarative and procedural memory systems in the building of speech representations may imply that problems with phonology may stem from selective weaknesses in declarative or procedural memory in predictive ways.
The first project Aim is to identify the memory substrates of novel phonetic category formation. In Experiment 1, the investigators will obtain behavioral measures of declarative, procedural, and speech sound learning before and after post-training sleep in 40 typical adults and 20 adults with LI. Among typical adults, a double dissociation is predicted in which speech identification will be predicted by individual differences in declarative memory, and speech discrimination will be predicted by individual differences in procedural memory. Moreover, adults with LI are predicted to demonstrate consolidation deficits across memory types.
The second project Aim is to identify the neural substrates of phonetic category formation. In Experiment 2, the investigators will obtain functional magnetic resonance (fMRI) recordings of 20 TD and 20 LI adults performing post-training identification and discrimination tasks on a trained speech contrast before and after sleep. In typical adults, a Time by Speech-task interaction is predicted. Speech identification will recruit episodic (hippocampal) information on Day 1 relative to classic regions for phonological processing on Day 2. Speech discrimination will result in a change in magnitude of activation from Days 1 and 2 in the left inferior frontal gyrus (IFG), reflecting an overnight decrease in effort. LI (n=20) is predicted to demonstrate reduced overnight change in neural activation relative to TD in both tasks.
Detailed description
The investigators will recruit 60 adults with typical language (TD) and 40 LI participants through a variety of community and university related contacts. 40 TD adults and 20 LI participants will be enrolled in Experiment 1. 20 TD adults and 20 LI participants will be enrolled in Experiment 2.
Both experiments will take place over 3 Sessions.
During Session 1, the investigators will administer various measures in order to validate study eligibility, classify participants into groups, and other measures in order to further characterize our samples. To that end, participants will be administered a pure tone audiometric screening, and complete an interview questionnaire asking for background information such as handedness, language background, language and reading development, and development of motor skills. Trained research personnel will then administer an approximately 2-hour testing battery that includes measures of nonverbal cognition, language ability, reading ability, attention, executive function, and phonological processing. Participants will also complete questionnaires to assess their habitual sleep quality, sleepiness, and individual chronotpyes.
All testing will be completed by a student clinician, and will be supervised by a certified speech-language pathologist. 100% of administrations will be re-scored by a trained student for accuracy. To account for attrition and non-qualifiers, we anticipate enrolling/screening up to 200 individuals in Session 1 in order to arrive at the enrollment targets for Experiments 1 and 2.
In both experiments, Sessions 2 and 3 takes place on two consecutive days. Session 2 will take place in the late evening, and Session 3 will take place in the morning. We have intentionally chosen not to employ a wake-state (AM-PM) control. This is done in order to limit the potential variability in the amount of English exposure between sessions. Between-session sleep duration will be monitored with an Actigraph wGT3X-BT accelerometer (Actigraph, corp) worn on the non-dominant wrist. Actigraphs will be set to collect data in 60-second epochs via a validated algorithm (Cain \& Geremia,2011). This method of recording sleep/wake activity has been independently validated to agree with lab polysomnography at 85% accuracy (Slater et al.,2015).
Experiment 1: behavioral measures During Session 2, participants will complete the three learning tasks, declarative learning, procedural learning, nonnative speech learning (in that order), and immediate post-learning assessments. During Session 3, participants will be re-assessed in nonnative speech learning, declarative learning, and procedural learning (in that order).
- Declarative memory will be assessed using an object recognition task following incidental encoding.
- A version of the Serial Reaction Time task will be used to measure procedural learning.
- Perceptual learning of speech will be measured through performance on identification and discrimination tasks on the dental and retroflex contrast.
Experiment 2: neuroimaging measures During Session 2, participants will complete the nonnative contrast training in the late evening. Then they will enter a magnetic resonance imagine (MRI) scanner, where their blood oxygen-level dependent signals will be recorded while they complete the post-training identification and discrimination assessments. The participants will complete the same in-scanner assessments of the perception of the nonnative contrast during Session 3.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a 2x2 mixed (Group by Time) design
| Arm | Type | Receives |
|---|---|---|
| behavioral | Experimental | Behavioral: behavioral trainingAdults with and without language impairment will be given three different types of behavioral training, and assessments of learning through those trainings, at two time points. |
| neuroimaging | Experimental | Behavioral: behavioral trainingFollowing speech sound behavioral training, adults with and without language impairment will undergo post-training perceptual assessments in an MRI scanner before and after post-training sleep. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Monolingual speakers of American English
- History of:
Key exclusion criteria (5 listed)
- Current diagnosis of ADHD
- Developmental dyslexia
- Rapid automatized naming deficits
- Neurological disorders
- Socio-emotional disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| behavioral trainingthe participants will be trained to perceive a non-native speech contrast | Behavioural | behavioral, neuroimaging |
Primary outcome
nonnative speech sound learning: behavioral measures of memory consolidation
Time frame: 2 days
learning will be assessed via behavioral performance (accuracy transformed to d') on perceptual tasks before training, after training, and after a post-training period of sleep
nonnative speech sound learning: fMRI measures of memory consolidation
Time frame: 2 days
change over a period of sleep in neural activation (BOLD response) in response to learned speech
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing behavioral training in people with Language Development Disorders, run by University of Delaware 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 6 inclusion and 5 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: paused, as of the sponsor's last update on 9 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nonnative speech sound learning: behavioral measures of memory consolidation (time frame: 2 days). The study lists 2 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 9 Jul 2020.