Dysphagia RehabilitationNCT07311161
Dysphagia Digital Therapy: A Pilot Study
A study testing "Pallow", mobile-based digital therapeutic (DTx) in people with Dysphagia Rehabilitation, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia Rehabilitation
- What is being tested?
- "Pallow", mobile-based digital therapeutic (DTx)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2024to 8 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Participants who need hospitalization (e.g. pneumonia)
- Requirement of surgical treatment during the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggi-do, 18450
About this study
Official title: The Efficacy of Dysphagia Digital Therapy in Patients With Various Swallowing Disorders: 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.
- Conditions
- Dysphagia Rehabilitation
- Being tested
- "Pallow", mobile-based digital therapeutic (DTx)
- Keywords
- mobile application, digital therapeutics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Pallow", mobile-based digital therapeutic (DTx)Device
mobile-based digital therapeutic (DTx) application designed for swallowing rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Patients with dysphagia | Experimental | Not described Receives: Device: "Pallow", mobile-based digital therapeutic (DTx) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of intervention at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 May 2024
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongtan Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311161
- Sponsor's protocol ID
- 2024-03-005
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Dysphagia Digital Therapy in Patients With Various Swallowing Disorders: A Pilot Study
- ClinicalTrials.gov ID
- NCT07311161
- Acronym / sponsor ID
- 2024-03-005
- Conditions
- Dysphagia Rehabilitation
- Keywords
- mobile application, digital therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dongtan Sacred Heart HospitalUniversity, hospital or other
- Study start
- 30 May 2024 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Patients with dysphagia | Experimental | Device: "Pallow", mobile-based digital therapeutic (DTx) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- Participants who need hospitalization (e.g. pneumonia)
- Requirement of surgical treatment during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Pallow", mobile-based digital therapeutic (DTx)mobile-based digital therapeutic (DTx) application designed for swallowing rehabilitation | Device | Patients with dysphagia |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Pallow", mobile-based digital therapeutic (DTx) in people with Dysphagia Rehabilitation, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penetration-Aspiration Scale (PAS) (time frame: From enrollment to the end of intervention at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.