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临床试验/NCT07154407
NCT07154407尚未招募不适用

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

Kaohsiung Medical University Chung-Ho Memorial Hospital0 个研究点目标入组 100 人开始时间: 2025年9月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Anterior tongue strength

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Anterior tongue strength

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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