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

Parkinson Disease Clinical Trial

— RHAPSODY  

Official title:

A Study to Investigate the Feasibility of Administration of a Speech Battery and the Use of Speech-based Biomarkers for the Clinical Assessment of Common Neurodegenerative and Psychiatric Disorders in a Remote Setting.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04939818
• Other study ID #: NOV-0200
• Status: Completed
• Start date: June 14, 2021
• Est. completion date: September 15, 2022

Study information

• Verified date: March 2023
• Source: Novoic Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: September 15, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Amyotrophic Lateral Sclerosis
• Aphasia
• Aphasia, Primary Progressive
• Bipolar Disorder
• Cognitive Dysfunction
• Dementia
• Dementia With Lewy Bodies
• Dementia, Vascular
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Frontotemporal Dementia
• Lewy Body Disease
• Major Depressive Disorder
• Mental Disorders
• Mild Cognitive Impairment
• Motor Neuron Disease
• Parkinson Disease
• Pick Disease of the Brain
• Primary Progressive Aphasia
• Problem Behavior

Locations

Country	Name	City	State
United Kingdom	King's College Hospital NHS Foundation Trust	London	Greater London
United Kingdom	South London and Maudsley NHS Foundation Trust	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
Novoic Limited	King's College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.		One week
Secondary	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
Secondary	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
Secondary	The subject average fraction of days during the first week of remote, self-assessment, where participants submitted at least one task response.		One week
Secondary	The average length of speech elicitation for each speech task, during the telemedicine video conference.		baseline
Secondary	The AUC of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.		One month
Secondary	The AUC of the binary classifier distinguishing between the Dementia with Lewy Bodies (LBD) diagnostic groups vs the applicable control group.		One month
Secondary	The AUC of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.		One month
Secondary	The AUC of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.		One month
Secondary	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
Secondary	The AUC of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.		One month
Secondary	The AUC of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.		One month
Secondary	The sensitivity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.		One month
Secondary	The specificity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.		One month
Secondary	The Cohen's kappa of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.		One month
Secondary	The Cohen's kappa of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.		One month
Secondary	The Cohen's kappa of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.		One month
Secondary	The Cohen's kappa of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.		One month
Secondary	The Cohen's kappa of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.		One month
Secondary	The Cohen's kappa of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.		One month
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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