Oral Motor and Cognitive Dual-Task Training for Oral Frailty and Cognitive Impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study tests a novel Oral Motor and Cognitive Dual-Task Training (OMCDT) program that combines oral motor exercises with cognitive tasks. Participants will complete OMCDT sessions weekly for 32 weeks and attend lab visits at 16 and 32 weeks for assessments. The trial also includes a safety evaluation of a drug labeled ABC. The approach aims to see whether dual-task training can simultaneously enhance oral function and cognition in adults aged 50 and older who speak Cantonese and meet specific oral frailty and cognitive criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults aged 50 years or above;
2. Cantonese speaking;
3. 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;
4. 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;
5. Living independently or with partial assistance, defined as a score of Modified Barthel Index score greater than 60 out of 100;
6. Right-handed person to minimize variability in cortical activation patterns during fNIRS measurement;
7. Can understand the purpose and contents of this project and could give written consent.

Exclusion Criteria:

1. 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;
2. Have received other cognitive training in previous 6 month;
3. Have impaired vision or hearing capacity that cannot understand the training instructions;
4. Have a diagnosis of a neurological or psychiatric condition that could affect cognitive function;
5. Have terminal illness, Temporomandibular joint dysfunction (TMJ) disorders; Sjogren's (SHOW-grins) syndrome;
6. Have undergone glossectomy surgery;
7. have been taking drugs that affect cognitive function (e.g. Benzodiazepines, antidepressants, central nervous drugs).

Where it's running

• The Hong Kong Polytechnic University
  Kowloon, Hong Kong, Hong Kong Recruiting
• The Hong Kong Polytechnic University
  Kowloon, Hong Kong, Hong Kong Enrolling by invitation

Study contacts

• Study coordinator: Yaqi Huang, Ph.D.
• Email: kitty.huang@polyu.edu.hk
• Phone: +852 34008192

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.