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NCT07733726

Overview

NCT ID: NCT07733726
Lead Sponsor: The Hong Kong Polytechnic UniversityOTHER
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
Brief Summary: 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
Conditions: Oral Frailty
Mild Cognitive Impairment (MCI)
Moderate Cognitive Impairment

Status and Timeline

Status: Enrolling by invitation
Last Update Posted: Jul 29, 2026Actual
Start Date: May 1, 2026Actual
Primary Completion Date: Dec 30, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
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).

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 66Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: The Hong Kong Polytechnic University

Similar Studies

Participant Group/Arms

Oral Motor and Cognitive Dual-Task Training (OMCDT) intervention groupExperimental

The participants will be instructed to relax as much as possible, and the surrounding environment will be set up as monotonous as possible. Only one PC, one (NIRS) with its accessories will be placed on a table. Particularly, at Week 1, Week 16 and Week 32, participants will be instructed to sit in a comfortable chair in front of the PC and wear the NIRS device. The intervention will be carried out follow the modified OCMDT protocol. Each weekly session includes 28 small training activities lasting about 40 min for 32 weeks.

Other: Oral Motor and Cognitive Dual-Task Training (OMCDT)

Control GroupNo Intervention

The participants in the control group will receive usual care

Oral motor exercise groupExperimental

Participants in the oral motor exercise group will receive evidence-based oral motor exercises without cognitive training. 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.

Behavioral: Oral motor exercise