Dysphagia Digital Therapy: A Pilot Study

Dongtan Sacred Heart Hospital

Status: Completed

Conditions: Dysphagia Rehabilitation

Treatments: Device: "Pallow", mobile-based digital therapeutic (DTx)

Study type: Interventional

Funder types: Other

Identifiers

NCT07311161

2024-03-005

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Patients with dysphagia

Experimental group

Treatment:

Device: "Pallow", mobile-based digital therapeutic (DTx)