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 Purpose:

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.

Study Status:

Not recruiting

Disease:

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

Study Type:

Observational [Patient Registry]

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

Allan Young, Professor, King's College London

Clinicaltrials.gov ID:

NCT04939818

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

Novoic Limited

Estimated Enrollment:

172

Estimated Study Start Date:

06 / 14 / 2021

Estimated Study Completion Date:

09 / 15 / 2022

Posting Last Modified Date:

03 / 22 / 2023

Date Study Added to neals.org:

06 / 25 / 2021

Minimum Age:

18 Years

Maximum Age:

85 Years

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

South London and Maudsley NHS Foundation Trust

London, Greater London SE5 8AZ
United Kingdom

King's College Hospital NHS Foundation Trust

London, Greater London SE5 9RS
United Kingdom