AI-Enabled Mobile App for Safe Eating in Older Adults With Dysphagia (NCT07654088) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AI-Enabled Mobile App for Safe Eating in Older Adults With Dysphagia
Hong Kong332 participantsStarted 2028-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial is testing an AI-powered mobile app to help people with swallowing difficulties stick to their prescribed food textures, would this kind of technology actually be practical for me to use given my current level of swallowing difficulty and comfort with smartphones?
2The trial is listed as 'not yet recruiting' — do you know when it might open for enrollment, and is there anything I should be doing in the meantime to manage my dysphagia safely while I wait?
3Because this is a Phase N/A study focused on a digital tool rather than a drug or procedure, what does that mean for what's already known about its safety, and are there any risks I should understand before considering participation?
4The trial is measuring how often participants actually eat meals that match their prescribed texture level — does that suggest my current adherence to my texture diet is something you're concerned about, and could a tool like this help me regardless of whether I join the trial?
5Are there established, non-experimental approaches to managing my dysphagia and prescribed texture diet that you would recommend I try first before considering a trial like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Meals Adhering to Prescribed Texture Level