Clinical trial NCT05298501: Assessing Performance on Speech Tasks Via Crowdsourced Participants
Official title: AMYWEB Validation Studies: Assessing Performance on Speech Tasks Via Crowdsourced Participants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Impairment
Mild Cognitive Impairment
Lead sponsor: Novoic Limited
Sponsor class: INDUSTRY
First posted: 2022-03-28
Enrollment: 1034
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited online, primarily through crowdsourcing websites.

Brief summary: The purpose of the study is to examine the properties of the Automatic Story Recall Test (ASRT) and its parallel variants, as well as letter fluency and category fluency cognitive tests. Tests will be completed in crowdsourced populations, to derive normative data, and examine test properties in demographically diverse and cognitively impaired participants recruited and tested online.

Detailed description: The AMYWEB study will validate speech tasks developed by NOVOIC in different population samples, including normative samples, samples recruited for enhanced demographic diversity, and participants with reported cognitive impairment.

Participants will be research volunteers recruited online and via crowdsourcing platforms. Six rounds of recruitment will be completed, evaluating different parallel variants of the Automatic Story Recall Task (ASRT), and fluency tasks. During each recruitment round participants will complete a speech test battery and questionnaires during one assessment (Baseline). Speech tasks will be recorded and later analyzed on Novoic's technology platform. All assessments will be fully online and remote.

Eligibility criteria: Inclusion Criteria:

* First language must be English
* Residing in the USA
* Willing to participate in a study investigating speech and dementia
* Able to provide informed consent
* Access to personal computing device that is capable of audio and video recording, and able to connect to the internet

Since key research questions are focused primarily on older-age speech and cognition, initial recruitment will be focused on older adult age brackets, which may be extended to younger adulthood if the desired sample sizes are not attained.

Exclusion Criteria:

* No formal exclusion criteria will apply at the point of recruitment and testing. however, participants with a reported history of neurological conditions or head injury, and current depression will be excluded from normative data development.

Primary outcomes:
measure: Age, sex, and education adjusted normative scores for the Automatic Story Recall Task (ASRT) test variants derived via linear regression analysis.
timeFrame: Baseline
Secondary outcomes:
measure: Normative data will be derived for shorter variants of the ASRT test battery derived via linear regression analysis.
timeFrame: Baseline
measure: Age, sex, and education adjusted normative scores for the category fluency task performance derived via linear regression analysis.
timeFrame: Baseline
measure: Age, sex, and education adjusted normative scores for the letter fluency task performance derived via linear regression analysis.
timeFrame: Baseline
measure: The effect of demographic differences on task performance will be evaluated via linear regression analysis.
timeFrame: Baseline
measure: Demographic and cultural biases will be examined via group or pairwise comparison of transcription error rate and scoring errors on a simple reading task.
timeFrame: Baseline
measure: Performance differences in parallel ASRT variant tasks will be examined via task-wise comparison.
timeFrame: Baseline
measure: Area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between the MCI sample and the normative sample using as input the speech elicited during cognitive tasks.
timeFrame: Baseline
measure: Area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between depressed and non-depressed participants using as input the speech elicited during cognitive tasks.
timeFrame: Baseline
measure: The agreement between the PHQ-8 and the corresponding regression model predicting depressive symptomatology from speech data elicited during tasks will be evaluated.
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Novoic Ltd
Study officials:
References: