NCT05901493

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Oct 2022Jul 2027

Study Start

First participant enrolled

October 23, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 13, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

June 12, 2024

Status Verified

June 1, 2024

Enrollment Period

4.2 years

First QC Date

May 19, 2023

Last Update Submit

June 10, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Speech discrimination - behavior

    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

    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 Outcomes (1)

  • Speech discrimination - Event-related potential of the electroencephalogram (ERP/EEG)

    1 event-related potential (ERP) session 1 week following training

Study Arms (6)

Blocked Evening Only Training

EXPERIMENTAL

One hour training in the evening, followed by a one hour training 24 hours later

Behavioral: Perceptual category training

Distributed Evening Training

EXPERIMENTAL

One hour training in the evening, followed by a two 30 min trainings 12 and 24 hours later

Behavioral: Perceptual category training

Blocked Evening-Morning Training

EXPERIMENTAL

One hour training in the evening, followed by a one hour training 12 hours later

Behavioral: Perceptual category training

Blocked Morning Only Training

EXPERIMENTAL

One hour training in the morning, followed by a one hour training 24 hours later

Behavioral: Perceptual category training

Distributed Morning Training

EXPERIMENTAL

One hour training in the morning, followed by a two 30 min trainings 12 and 24 hours later

Behavioral: Perceptual category training

Blocked Morning-Evening Training

EXPERIMENTAL

One hour training in the morning, followed by a one hour training 12 hours later

Behavioral: Perceptual category training

Interventions

Participants complete a forced-choice categorization task with feedback, in order to learn difficult auditory and visual categories

Blocked Evening Only TrainingBlocked Evening-Morning TrainingBlocked Morning Only TrainingBlocked Morning-Evening TrainingDistributed Evening TrainingDistributed Morning Training

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • native speakers of American English
  • Grew up in a household in which only American English was spoken
  • 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

You may not qualify if:

  • History of neurological disorders
  • History of psychiatric disorders
  • History of socio-emotional disorders
  • On prescription medication(s) that alter sleep

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

Northeastern University

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Language Development Disorders

Condition Hierarchy (Ancestors)

Language DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Frances Earle, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be assigned to one of six training schedules to complete over 48 hours. All participants will complete the same amount of training. The investigators will examine retention of trained information at the end of the week.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2023

First Posted

June 13, 2023

Study Start

October 23, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

July 31, 2027

Last Updated

June 12, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

de-identified data will be uploaded to the Open Science Framework alongside publications to stem from data from this project

Shared Documents
ANALYTIC CODE
Time Frame
This data will be made available upon publication of the data, indefinitely

Locations