AI-assisted Masticatory Muscle Training in Patients With Schizophrenia

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia Disorder

• Registration Number: NCT07154407
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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.

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-26
• Last Update Submitted: 2025-08-26
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Study Start: 2025-09-11
• Primary Completion: 2027-09-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anterior tongue strength	From day 1 of enrollment to the end of the treatment period (up to 3 months)	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
Posterior tongue strength	From day 1 of enrollment to the end of the treatment period (up to 3 months)	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
Masticatory Performace	From day 1 of enrollment to the end of the treatment period (up to 3 months)	Using colour-changing chewing gum to assess the ability, the colour would be changed according to the frequency of chewing
Oral Hygiene	From day 1 of enrollment to the end of the treatment period (up to 3 months)	Using the Plaque index, Winkle tongue-coating index to assess participants' oral hygiene
Swallowing Performance	From day 1 of enrollment to the end of the treatment period (up to 3 months)	Using the Repetitive Saliva Swallowing Test to assess the ability to swallow. The times of participants swallowed within 30 seconds would be recorded
Oral Care Behaviours	From day 1 of enrollment to the end of the treatment period (up to 3 months)	Using a survey to collect participants' behaviours
Cognitive Function	From day 1 of enrollment to the end of the treatment period (up to 3 months)	Using MoCA to assess cognitive ability once at the beginning of the experiment