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OpenTrials
Completed

NCT Number: NCT07311161

Dysphagia Digital Therapy: A Pilot Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hallym University Dongtan Sacred Heart Hospital

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

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

Device

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

Primary outcomes

  1. Penetration-Aspiration Scale (PAS)

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

    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.

Sponsors and collaborators

Lead sponsor

Dongtan Sacred Heart Hospital

Other

Registry information

Official study title

The Efficacy of Dysphagia Digital Therapy in Patients With Various Swallowing Disorders: A Pilot Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2025
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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