AI-assisted Masticatory Muscle Training in Patients With Schizophrenia

NCT07154407 | Not Yet Recruiting DMC

• 1 other identifier: KMUHIRB-F(I)-20240124
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dysphagia seems to be quite common and potentially severe in schizophrenia, which may lead to acute asphyxia or pneumonia. Dysphagia in schizophrenia could be associated with drug-induced Parkinsonism, dystonia, tardive dyskinesia, dry mouth, excessive saliva, and other complications. Inadequate oral hygiene may lead to the accumulation of plaque, which can cause oral diseases and consequently result in tooth loss. This could be one of the significant factors affecting impaired masticating and swallowing abilities. An experimental study with random assignment will be adopted. The participants from 2 hospitals will be assigned to two groups: experimental group (n=50), and control group (n=50). The experimental group will receive 'AI-assisted Masticatory Muscle Training' sessions, each lasting 20 minutes, before each of their three daily meals. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month follow-ups.

Conditions

Schizophrenia Disorder

Keywords

Masticatory Muscle Training; AI-assisted; Oral Hygiene; Masticate; Swallow

Outcome Measures

Primary Outcomes (7)

• Anterior tongue strength

  Using the IPOI machine to test participants' tongue strength once a month for a total of 3 months, and a follow-up review 3 months after the end of treatment

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

• Posterior tongue strength

  Using the IPOI machine to test participants' tongue strength once a month for a total of 3 months, and a follow-up review 3 months after the end of treatment

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

• Masticatory Performace

  Using colour-changing chewing gum to assess the ability, the colour would be changed according to the frequency of chewing

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

• Oral Hygiene

  Using the Plaque index, Winkle tongue-coating index to assess participants' oral hygiene

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

• Swallowing Performance

  Using the Repetitive Saliva Swallowing Test to assess the ability to swallow. The times of participants swallowed within 30 seconds would be recorded

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

• Oral Care Behaviours

  Using a survey to collect participants' behaviours

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

• Cognitive Function

  Using MoCA to assess cognitive ability once at the beginning of the experiment

  From day 1 of enrollment to the end of the treatment period (up to 3 months)

Study Arms (2)

Intervented group

EXPERIMENTAL

The group member (n=50) will receive 'AI-assisted Masticatory Muscle Training' sessions, each lasting 20 minutes, before each of their three daily meals. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month and 6-month follow-ups.

Other: AI-assisted Mastisting Training App

Controlled group

NO INTERVENTION

The control group (n=50) will be maintained their scheduled activities in daycare as usual. The plaque index, Winkle tongue-coating index, dry mouth, repetitive saliva swallowing, saliva flow rate, biting force, tongue pressure, oral frailty, RSST, DDK, and oral care behaviors were assessed at baseline, as well as during the 3-month and 6-month follow-ups.

Interventions

AI-assisted Mastisting Training App OTHER

An artificial intelligence (AI) recognition system for the 'AI-assisted Masticatory Muscle Training,' tailored to train masticatory muscles in patients with schizophrenia. By finishing certain exercise per day, expecting the experimental oral hygience, masticating and swallowing fuction could be advanced,

Intervented group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Psychiatric Outpatient Ward Schizophrenia Diagnosed patient with 20 years or above
• Without Violence or suicidal tendencies
• With a self-owned smartphone
• Able to stabilise the IOPI machine while testing
• Able to communicate

You may not qualify if:

• Severe psychiatric symptoms
• With medical history which affects oral hygiene and masticating function severely (such as stroke, oral cavity-related cancer, periodontitis)
• Severe cognitive function with a score of less than 16 marks in the MoCA Test
• Indicated with Motor Neuron Disease
• Joining multiple Intervention Experiments simultaneously

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Hsieh Hsiu Fen, PhD

  Kaohsiung medical university nursing faculty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsieh Hsiu Fen, PhD

CONTACT

886-312-1101; hsiufen96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 4, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 4, 2025

Record last verified: 2025-04