Validation of acceXible's Automated Speech Analysis Method for the Early Detection and Monitoring of Patients With Mild Impairment or Dementia in Primary Care

Sponsor
Accexible (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05380297
Collaborator
(none)
248
1
33
7.5

Study Details

Study Description

Brief Summary

Dementia, especially dementia caused by Alzheimer's disease, is considered one of the most severe health problems of our time. It is currently known that the disease begins many years before clinical symptoms appear. The sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration.

A recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. It can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness.

Thus, the purpose of this study is to validate speech analysis AI models.

Condition or Disease Intervention/Treatment Phase
  • Device: Speech analysis
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
248 participants
Allocation:
N/A
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Validación Del método de análisis Automatizado Del Habla "AcceXible" Para la detección Temprana y Seguimiento de Pacientes Con Deterioro Cognitivo Leve o Demencia en atención Primaria.
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Vocal biomarkers to assess pre-post variability of normal, MCI and dementia at both point of the study. [Change from the baseline cognitive function at 9 months.]

    Standard deviation of normal subjects, MCI and dementia to measure variations in language by using vocal biomarkers.

Secondary Outcome Measures

  1. Correlation between standard cognitive test (MMSE) and linguistic variables obtained by vocal biomarkers. [Through study completion, an average of 1 year.]

    With a 95% confidence interval, the correlation between standard cognitive test (MMSE score) and each of the linguistic variables is quantified.

Other Outcome Measures

  1. Change of economic implications of accexible's use in a primary care center. [Through study completion, an average of 1 year.]

    Percentage of expenditure when using the platform.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Adult patients 55+ years of age with suspected MCI or diagnosis of dementia and obtains a score greater than 20 on the MMSE.

  • Patients must have agreed to participate in the study and have voluntarily signed the informed consent.

  • (Healthy) Participants without a diagnosis neurological, or psychiatric disorders. Or taking medication that can affect cognitive abilities.

Exclusion Criteria

  • To have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration.

  • To have significant vision problems that would affect the ability to perceive visual stimuli.

  • To have significant hearing problems that would affect the ability to understand verbal cues.

Contacts and Locations

Locations

Site City State Country Postal Code
1 País Vasco País Vasco Spain

Sponsors and Collaborators

  • Accexible

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Accexible
ClinicalTrials.gov Identifier:
NCT05380297
Other Study ID Numbers:
  • PS2020056
First Posted:
May 18, 2022
Last Update Posted:
May 18, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022