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NCT07654088
AI-Enabled Mobile App for Safe Eating in Older Adults With Dysphagia
Conditions: Deglutition Disorders, Dysphagia
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 332
Sponsor: KAM Chi Shan Anna
Location: The Education University of Hong Kong Hong Kong
Summary
Difficulty swallowing (called dysphagia) is common in older adults and can make eating and drinking unsafe. It may lead to serious problems such as choking, lung infections, poor nutrition, and reduced quality of life. One common way to reduce these risks is to modify food and drink textures (for example, making foods softer or liquids thicker). However, people often find it difficult to prepare food at the correct texture level in everyday life, especially at home, which may reduce the effectiveness of this approach.
This study aims to test whether a smartphone application powered by artificial intelligence (AI) can help older adults with swallowing difficulties eat more safely. The app allows users (or their caregivers) to take a photo of food or drinks, and the app then estimates the texture level and provides guidance to help ensure it is safe to swallow. It also gives simple prompts to double-check food texture when needed.
In this clinical trial, community-dwelling adults aged 60 years or above with swallowing difficulties will be randomly assigned to one of two groups. One group will receive usual care, which includes education about safe swallowing and written instructions on appropriate food textures. The other group will receive the same usual care plus access to the AI-enabled mobile app for 16 weeks. Participants will continue their daily eating routines at home.
The main question this study is trying to answer is: Does using the AI-enabled mobile app improve how often people eat foods that match their recommended safe texture level compared with usual care alone?
The study will also examine whether the app helps reduce swallowing-related problems (such as choking), improves quality of life, and supports better overall eating ability. In addition, the study will evaluate how easy the app is to use and whether it places any burden on users.
Hypothesis: The researchers hypothesize that participants who use the AI-enabled app, in addition to usual care, will more consistently follow recommended food texture guidelines and experience safer eating compared with those who receive usual care alone.
Eligibility Criteria
Inclusion Criteria:
* Adults aged 60 years or above
* Community-dwelling (living in a home or community setting)
* Suspected or clinically identified oropharyngeal dysphagia
* Currently consuming food or liquids orally at texture-modified levels
* Able to provide informed consent, or with caregiver support if mild cognitive impairment is present
* Access to a smartphone or tablet, either independently or with caregiver assistance
* Willing and able to participate in study procedures and follow-up assessments
Exclusion Criteria:
* Exclusive dependence on non-oral feeding (e.g., tube feeding)
* Severe cognitive impairment or severe visual impairment that prevents meaningful participation
* Medical conditions or circumstances that make participation unsafe
* Life expectancy less than 6 months
* Current participation in another dysphagia-related interventional study
* Use of other digital tools specifically designed for food texture classification during the study period
Source: ClinicalTrials.gov (NCT07654088). StuddyBuddy aggregates publicly available trial information.