跳至主要内容
临床试验/NCT07311161
NCT07311161已完成不适用

The Efficacy of Dysphagia Digital Therapy in Patients With Various Swallowing Disorders: A Pilot Study

Dongtan Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年5月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
Penetration-Aspiration Scale (PAS)

研究概览

简要总结

Dysphagia is a swallowing disorder characterized by impaired transfer of food or liquid from the oral cavity through the pharynx and esophagus, leading to significant nutritional, respiratory, and quality-of-life consequences.

Despite these advances, existing dysphagia rehabilitation programs are largely limited to specific disease groups, restricting their generalizability. In clinical practice, dysphagia arises from diverse etiologies, including stroke, neurodegenerative diseases, and other neurological or muscular conditions, which share common rehabilitation goals such as safe swallowing, aspiration prevention, and maintenance of oral intake.

This pilot study aimed to evaluate the feasibility and preliminary effectiveness of a novel mobile-based digital therapeutic (DTx) application for dysphagia rehabilitation across a clinically heterogeneous population. The DTx platform leverages mobile device camera signals to provide real-time feedback, structured reminders, and quantitative monitoring of self-directed training. We hypothesized that integrating this DTx into dysphagia care would enhance patient engagement, adherence, and swallowing-related outcomes. The findings of this study are expected to inform future large-scale trials and support the broader implementation of digital therapeutics in dysphagia rehabilitation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

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

入选标准

  • Aged ≥18 years with dysphagia from head and neck cancer surgery/chemotherapy, cerebrovascular/neurodegenerative diseases, or neuromuscular diseases
  • Swallowing difficulty, indicated by Penetration-Aspiration Score (PAS) ≥2 by VFSS
  • Ability to sit for more than 30 minutes
  • no significant cognitive impairment and mobile device access (MMSE>24)

排除标准

  • Participants who need hospitalization (e.g. pneumonia)
  • Requirement of surgical treatment during the study

结局指标

主要结局

Penetration-Aspiration Scale (PAS)

时间窗: From enrollment to the end of intervention at 4 weeks

Penetration and aspiration are evaluated using an 8-point scale during a Videofluoroscopic Swallowing Study (VFSS) to determine the severity of airway invasion. Scores range from 1 (normal) to 8 (material passes below the vocal folds with no effort to eject). The higher the score, the more severe the dysphagia.

次要结局

未报告次要终点

研究者

发起方
Dongtan Sacred Heart Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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