Dysphagia Digital Therapy: A Pilot Study

Dongtan Sacred Heart Hospital10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Dysphagia Rehabilitation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged ≥18 years with dysphagia from head and neck cancer surgery/chemotherapy, cerebrovascular/neurodegenerative diseases, or neuromuscular diseases 2. Swallowing difficulty, indicated by Penetration-Aspiration Score (PAS) ≥2 by VFSS 3. Ability to sit for more than 30 minutes 4. no significant cognitive impairment and mobile device access (MMSE\>24) Exclusion Criteria: 1. Participants who need hospitalization (e.g. pneumonia) 2. Requirement of surgical treatment during the study

Outcomes

Primary Outcomes

Penetration-Aspiration Scale (PAS)

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.

Time frame: From enrollment to the end of intervention at 4 weeks