Skip to content

AI-assisted Masticatory Muscle Training in Patients With Schizophrenia

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07154407
Acronym
AI-assisted
Enrollment
100
Registered
2025-09-04
Start date
2025-09-11
Completion date
2027-12-31
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia Disorder

Keywords

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

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.

Interventions

OTHERAI-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,

Sponsors

Kaohsiung Medical University Chung-Ho Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Anterior tongue strengthFrom 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 strengthFrom 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 PerformaceFrom 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 HygieneFrom 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 PerformanceFrom 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 BehavioursFrom day 1 of enrollment to the end of the treatment period (up to 3 months)Using a survey to collect participants' behaviours
Cognitive FunctionFrom 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

Contacts

Primary ContactHsieh Hsiu Fen, PhD
hsiufen96@gmail.com886-312-1101

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026