Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders

Completed

• Conditions: Primary Progressive Aphasia; Bipolar Disorder; Alzheimer Disease; Dementia With Lewy Bodies; Frontotemporal Dementia; Parkinson Disease; Amyotrophic Lateral Sclerosis; Mild Cognitive Impairment; Dementia, Vascular; Motor Neuron Disease

• Registration Number: NCT04939818
• Lead Sponsor: Novoic Limited

Brief Summary

The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of self-assessment. Secondary objectives include (1) evaluating the reliability of speech tasks in the remote self-administered setting, as measured by the intra- and inter-subject variance; (2) accessing the adherence of speech tasks in this setting, as measured by the subject average fraction of days during the first week, where at least one task response is submitted; (3) evaluating the feasibility of using speech tasks in the setting of a telemedicine videoconference, as measured by the average length of speech elicited in each group; (4) evaluate whether a set of acoustic and linguistic patterns can detect each indication, compare to either a control group or all other indications, as measured by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5) evaluating how the performance of such algorithms can be impacted by speaker and environment covariates, as measured by the Kendall rank correlation coefficient of the AUC of each classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-11
• Study Start: 2021-06-14
• Study First Submitted QC: 2021-06-17
• Study First Posted: 2021-06-25
• Primary Completion: 2022-09-15
• Study Completion: 2022-09-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• Willing to participate, having been provided full information about the study components and details.
• Native language is English.
• Has the capacity to provide fully informed consent.
• Has access to and able to use, or has a caregiver who has access to and able to use a smartphone device running an operation system of iOS 11.0 or later, or Android 7.0 or later.
• Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
• Has access to a personal computer, notebook or tablet that is (1) Running an operating system of:

macOS X with macOS 10.9 or later; OR Windows 7 or above; AND (2) Capable of audio recording; AND (3) Able to connect to the internet; AND (4) Have access to one of following internet browser software: Internet Explorer version 11 or above; OR Microsoft Edge version 12 or above; OR Firefox version 27 or above; OR Google Chrome version 30 or above; OR Safari version 7 or above.

Exclusion Criteria

• Diagnosis of alcohol or drug use disorder;
• History or presence of stroke within the past 2 years;
• Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
• At risk of suicide: score of 10 or above on the PHQ scale, and 10 or above on the MINI suicide questionnaire

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.	One week

Secondary Outcome Measures

Name	Time	Method
The AUC of the binary classifier distinguishing between the Dementia with Lewy Bodies (LBD) diagnostic groups vs the applicable control group.	One month
The AUC of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.	One month
The AUC of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.	One month
For each classifier/regressor in the outcomes, the correlation between the AUC/CIA and each age group, gender and speech-to-reverberation modulation energy ratio group, as measured by the Kendall rank correlation coefficient.	One month
The intra-subject variance of length of speech elicitation for each speech task during the first week of self-assessments, as measured by Coefficients of Individual Agreement (CIA).	One week
The subject average fraction of days during the first week of remote, self-assessment, where participants submitted at least one task response.	One week
The AUC of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.	One month
The AUC of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.	One month
The specificity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.	One month
The specificity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.	One month
The sensitivity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.	One month
The Cohen's kappa of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.	One month
The inter-subject variance of length of speech elicitation for each speech task during the first week of self-assessments, as measured by Coefficients of Individual Agreement (CIA).	One week
The AUC of the binary classifier distinguishing between the Frontotemporal Dementia and Vascular Dementia (FTD/VCI) diagnostic groups vs the applicable control group.	One month
The AUC of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.	One month
The specificity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.	One month
The specificity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.	One month
The Cohen's kappa of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.	One month
The Cohen's kappa of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.	One month
The specificity of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.	One month
The average length of speech elicitation for each speech task, during the telemedicine video conference.	baseline
The specificity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.	One month
The specificity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.	One month
The Cohen's kappa of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.	One month
The Cohen's kappa of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.	One month
The AUC of the binary classifier distinguishing between the following diagnostic groups vs all other diagnostic groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.	One month
The sensitivity of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.	One month
The Cohen's kappa of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.	One month
The Cohen's kappa of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.	One month
The specificity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.	One month

Trial Locations

Locations (2)

South London and Maudsley NHS Foundation Trust; 🇬🇧 London, Greater London, United Kingdom

King's College Hospital NHS Foundation Trust; 🇬🇧 London, Greater London, United Kingdom