Schizophrenia DisorderAI-assistedNCT07154407
AI-assisted Masticatory Muscle Training in Patients With Schizophrenia
A study testing AI-assisted Mastisting Training App in people with Schizophrenia Disorder, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia Disorder
- What is being tested?
- AI-assisted Mastisting Training App
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia Disorder
- Being tested
- AI-assisted Mastisting Training App
- Keywords
- Masticatory Muscle Training, AI-assisted, Oral Hygiene, Masticate, Swallow
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-assisted Mastisting Training AppOther
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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From day 1 of enrollment to the end of the treatment period (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start11 Sep 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Schizophrenia DisorderStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsieh Hsiu Fen, PhD, Principal investigator, Kaohsiung medical university nursing faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154407
- Sponsor's protocol ID
- KMUHIRB-F(I)-20240124
- Acronym
- AI-assisted
- Status last verified
- Apr 2025
- First submitted
- 11 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT07154407
- Acronym / sponsor ID
- AI-assisted / KMUHIRB-F(I)-20240124
- Conditions
- Schizophrenia Disorder
- Keywords
- Masticatory Muscle Training, AI-assisted, Oral Hygiene, Masticate, Swallow
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- 11 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervented group | Experimental | Other: AI-assisted Mastisting Training AppThe 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-assisted Mastisting Training AppAn 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, | Other | Intervented group |
Primary outcome
Anterior tongue strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hsieh Hsiu Fen, PhD principal investigator
Kaohsiung medical university nursing faculty
Questions about this trial
What is this clinical trial studying?
A study testing AI-assisted Mastisting Training App in people with Schizophrenia Disorder, run by Kaohsiung Medical University Chung-Ho Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hsieh Hsiu Fen, PhD (886-312-1101 ext. 2626, hsiufen96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior tongue strength (time frame: From day 1 of enrollment to the end of the treatment period (up to 3 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.