NCT04939818已完成不适用
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.
Novoic Limited2 个研究点 分布在 1 个国家目标入组 172 人开始时间: 2021年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.
时间窗: One week
次要结局
- 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 LBD diagnostic groups vs the applicable control group.(One month)
- 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)
研究者
研究点 (2)
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