Clinical trial NCT04939818: Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Dementia With Lewy Bodies
Dementia, Vascular
Frontotemporal Dementia
Primary Progressive Aphasia
Parkinson Disease
Motor Neuron Disease
Major Depressive Disorder
Bipolar Disorder
Amyotrophic Lateral Sclerosis
Keywords: Speech
Acoustic
Language
Linguistic
Machine Learning
Artificial Intelligence
Lead sponsor: Novoic Limited
Sponsor class: INDUSTRY
Collaborators: name: King's College London
First posted: 2021-06-25
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population is UK-based.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.
timeFrame: One week
Secondary outcomes:
measure: 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).
timeFrame: One week
measure: 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).
timeFrame: One week
measure: The subject average fraction of days during the first week of remote, self-assessment, where participants submitted at least one task response.
timeFrame: One week
measure: The average length of speech elicitation for each speech task, during the telemedicine video conference.
timeFrame: baseline
measure: The AUC of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The AUC of the binary classifier distinguishing between the Dementia with Lewy Bodies (LBD) diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The AUC of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The AUC of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The AUC of the binary classifier distinguishing between the Frontotemporal Dementia and Vascular Dementia (FTD/VCI) diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The AUC of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The AUC of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The sensitivity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The specificity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The Cohen's kappa of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The Cohen's kappa of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The Cohen's kappa of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The Cohen's kappa of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The Cohen's kappa of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: The Cohen's kappa of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
timeFrame: One month
measure: 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.
timeFrame: One month
measure: 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.
timeFrame: One month
measure: 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.
timeFrame: One month
measure: 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.
timeFrame: One month
measure: 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.
timeFrame: One month
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: South London and Maudsley NHS Foundation Trust
state: Greater London
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
state: Greater London
Study officials:
affiliation: King's College London
name: Allan Young, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hampsey E, Meszaros M, Skirrow C, Strawbridge R, Taylor RH, Chok L, Aarsland D, Al-Chalabi A, Chaudhuri R, Weston J, Fristed E, Podlewska A, Awogbemila O, Young AH. Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders. BMJ Open. 2022 Jun 6;12(6):e061193. doi: 10.1136/bmjopen-2022-061193.