AI-assisted Masticatory Muscle Training in Patients With Schizophrenia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI-assisted Mastisting Training App.
- Who it may be relevant to
- Registry conditions: Schizophrenia Disorder. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia
Overview
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
- 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,
Primary outcome measures
- Anterior tongue strength [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
- Posterior tongue strength [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
- Masticatory Performace [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
- Oral Hygiene [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
- Swallowing Performance [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
- Oral Care Behaviours [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
- Cognitive Function [Time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07154407 · KMUHIRB-F(I)-20240124