Dysphagia Digital Therapy: A Pilot Study

NCT07311161 | Completed

• 1 other identifier: 2024-03-005
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysphagia Rehabilitation

Keywords

mobile application; digital therapeutics

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the end of intervention at 4 weeks

Study Arms (1)

Patients with dysphagia

EXPERIMENTAL

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

Interventions

"Pallow", mobile-based digital therapeutic (DTx) DEVICE

mobile-based digital therapeutic (DTx) application designed for swallowing rehabilitation

Patients with dysphagia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Dongtan Sacred Heart Hospital: lead

Study Sites (1)

Hallym University Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 18450, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This was a single-center, prospective, case series pilot study. Participants were diagnosed as dysphagia after VFSS. Two sessions of swallowing therapy and digital therapeutic (DTx) education were conducted by an occupational therapist to familiarize the participant. Each participant then performed individualized home-based swallowing exercises using the DTx application for 4 weeks, three times daily. The individuals allowed a preliminary evaluation of the feasibility and applicability of the mobile-based digital therapeutic intervention across a broad spectrum of dysphagia etiologies. The primary outcome of this study was the assessment of airway protection using the Penetration-Aspiration Scale (PAS) evaluated through videofluoroscopic swallowing study (VFSS).

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: May 30, 2024
• Primary Completion: April 8, 2025
• Study Completion: April 8, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

KR (1)