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Enrolling by invitation NCT07733726

Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for Improving Oral and Cognitive Functions Among People With Oral Frailty

No phase Interventional Oral Frailty Mild Cognitive Impairment (MCI) Moderate Cognitive Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Oral Motor and Cognitive Dual-Task Training (OMCDT), Oral motor exercise.
Who it may be relevant to
Registry conditions: Oral Frailty, Mild Cognitive Impairment (MCI), Moderate Cognitive Impairment. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Oral Motor and Cognitive Dual-Task Training (OMCDT) Program for People With Oral Frailty for Improving Oral and Cognitive Functions: a Feasibility Study

Overview

The goal of this clinical trial is to proposes a novel Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time. It will also learn about the safety of drug ABC. The main questions it aims to answer is: Does the OMCDT training can improve the oral and cognitive functions? Participants will: Take the OMCDT training once a week for 32 weeks Visit the lab twice in the intervention period (16-week, 32-week) for checkups and tests

Interventions

  • Other Oral Motor and Cognitive Dual-Task Training (OMCDT)
    Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines both oral motor exercises and cognitive tasks to improve brain and oral function at the same time, where the training includes 4 types of combined oral and cognitive functions.
  • Behavioral Oral motor exercise
    The intervention will include four components: tongue-lip coordination exercises, tongue muscle strengthening exercises, lip and cheek muscle strengthening exercises, and mastication exercises. Each component will be repeated for seven rounds, with a 10-second rest interval between rounds. The intervention will be delivered once per week.

Primary outcome measures

  • Proportion of participant randomized divided by proportion of people eligible [Time frame: Week 16; Week-32]
  • Number of participants that withdraw divided by number of participants randomized [Time frame: 16-week; 32-week]
  • Proportion of participants who complete the allocated intervention with a minimum of 80% attendance [Time frame: 16-week; 32-week]
Secondary outcome measures (7)
  • Maximum tongue pressure [Time frame: Baseline, 16-week, 32-week]
  • Oral motor coordination [Time frame: baseline; 16-week; 32-week]
  • Masticatory ability [Time frame: baseline; 16-week; 32-week]
  • Self-reported oral health [Time frame: Baseline, 16-week, 32-week]
  • Global cognitive status [Time frame: Baseline, 16-week, 32-week]
  • Executive function [Time frame: baseline; 16-week; 32-week]
  • Memory [Time frame: baseline; 16-week; 32-week]

Eligibility criteria

Inclusion criteria

  • Adults aged 50 years or above;
  • Cantonese speaking;
  • Having oral frailty, which is defined as having at least two of the following components by Oral Frailty Five-item Checklist (OF-5): (i) Natural teeth fewer than 20, (ii) Have any difficulties eating tough foods now compared with 6 months ago; (iii) Have choked on tea or soup recently; (iv) Often experience having a dry mouth, and (v) Oral diadochokinetic /ta/ sound <6.0 times/second;
  • Having subjective cognitive decline (SCD), which refers to self-reported experience of worsening or more frequent confusion or memory loss in the past 12 month, or having been diagnosed with mild or moderate cognitive impairment; defined as a score of 0.5, 1, or 2 on Clinical Dementia Rating (C.D.R) scale;
  • Living independently or with partial assistance, defined as a score of Modified Barthel Index score greater than 60 out of 100;
  • Right-handed person to minimize variability in cortical activation patterns during fNIRS measurement;
  • Can understand the purpose and contents of this project and could give written consent.

Exclusion criteria

  • Have attended the dental clinics for dental treatment or received orofacial myofunctional therapy (OMT), involving doing certain oral exercises with cheeks, tongue, or lips in previous 6 months;
  • Have received other cognitive training in previous 6 month;
  • Have impaired vision or hearing capacity that cannot understand the training instructions;
  • Have a diagnosis of a neurological or psychiatric condition that could affect cognitive function;
  • Have terminal illness, Temporomandibular joint dysfunction (TMJ) disorders; Sjogren's (SHOW-grins) syndrome;
  • Have undergone glossectomy surgery;
  • have been taking drugs that affect cognitive function (e.g. Benzodiazepines, antidepressants, central nervous drugs).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Kowloon

Identifiers

NCT: NCT07733726 · P0058617 · P0058617

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗