AI-assisted Masticatory Muscle Training in Patients With Schizophrenia (AI-assisted)

The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia Disorder
• Intervention / Treatment: Other: AI-assisted Mastisting Training App

Detailed Description

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 control group 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 follow-ups. Generalized Estimating Equations (GEE) were used to analyses the indicated effects.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsieh Hsiu Fen, PhD; Phone Number: 2626 886-312-1101; Email: hsiufen96@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervented group; 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; 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,
No Intervention: Controlled group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Investigators: Principal Investigator: Hsieh Hsiu Fen, PhD, Kaohsiung medical university nursing faculty

Study record dates

Study Major Dates

• Study Start (Estimated): September 11, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 26, 2025
• First Posted (Estimated): September 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: August 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Swallow; Oral Hygiene; AI-assisted; Masticatory Muscle Training; Masticate
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia
• Other Study ID Numbers: KMUHIRB-F(I)-20240124

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No