NCT06611475

Brief Summary

This study aims to explore the potential of using machine learning (ML) algorithms to predict cognitive status, specifically MMSE scores, based on oral health and demographic data. The objective is to evaluate the effectiveness of various ML models and identify the most relevant oral health indicators for predicting MMSE scores of 30 (normal cognition) or ≤26 (cognitive impairment) in individuals aged 60 and above.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 25, 2024

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2024

Completed
Last Updated

November 25, 2024

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

September 17, 2024

Last Update Submit

November 22, 2024

Conditions

Keywords

ClassificationMachine LearningMini-Mental State ExaminationCognitive ImpairmentOral Health

Outcome Measures

Primary Outcomes (1)

  • Detection perfomance

    The study measures the classification performance of Machine Learning classifiers. Performance metrics, Accuracy, precision, recall, F1-Score and confusion matrix will be used for the evaluation. The examination of the most important features relied on SHAP summary plots, providing visualizations of the influence of parameter groups on the output, organized by their importance. This importance is based on SHAP values, offering insights into features' effects on the ML model's decision-making process

    5 mounths

Study Arms (2)

MMSE ≤26

339 participants

Other: MMSE ≤26

MMSE 30

354 participants

Other: MMSE ≤26

Interventions

A dataset comprising participants with MMSE scores of ≤26 and 30 will be used to evaluate the classification performance of various machine learning techniques.

Also known as: MMSE 30
MMSE 30MMSE ≤26

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data collected from the European collaborative study Support Monitoring and Reminder Technology for Mild Dementia (SMART4MD) and the Swedish National Study on Aging and Care (SNAC-B) will be analyzed. Participants aged 60 years or older will be included in the analysis.

You may qualify if:

  • Individuals aged 60 years or older.
  • Participants with recorded oral health parameters and MMSE scores of either 30 or ≤26.

You may not qualify if:

  • Individuals with MMSE scores of 27, 28, or 29, as these scores represent a transition phase between normal cognition and cognitive impairment, which could introduce variability.
  • Individuals younger than 60 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blekinge institute of Technology

Karlskrona, 37179, Sweden

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2024

First Posted

September 25, 2024

Study Start

June 10, 2024

Primary Completion

October 10, 2024

Study Completion

November 10, 2024

Last Updated

November 25, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Participant data can not be shared due to the GDPR.

Locations