NCT Number: NCT07154407
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.
Trial opening soon.
Get Notified20 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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,
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
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
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
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
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
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
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
Contact information is provided by the study sponsor or research team.
Kaohsiung Medical University Chung-Ho Memorial Hospital
Other
The Effectiveness of AI-assisted Masticatory Muscle Training on Oral Hygiene, Masticating, and Swallowing in Patients With Schizophrenia
Acronym: AI-assisted
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