Clinical trial · Interventional
Swallowing Therapy With the Assistance of a Mobile Health Device in Head and Neck Cancer Patients: a Pan-Alberta Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Dysphagia affects 22% of those over the age of 50, which equates to 250 million people worldwide and 360,000 in Alberta. At high risk are survivors of head and neck cancer (70%). Difficulties with swallowing are not only life threatening and resource-intense, but also socially limiting. To regain swallowing function and avoid or reduce the consequences of dysphagia, patients require regular, intensive therapy over many months to strengthen swallowing muscles and improve swallow coordination. This therapy is often coupled with visual biofeedback that uses surface electromyography (sEMG). Despite evidence that swallowing exercises are effective when provided with an intensive regimen and when coupled with sEMG biofeedback, patients rarely receive it. The primary aim of this work is to determine whether the use of a mobile system equipped with sEMG biofeedback affects adherence to home-based swallowing exercises. The secondary aim of this work is to determine if the exercise program results in improved patient reported outcomes related to dysphagia and nutrition. Our tertiary aim is to determine if previous findings of adherence can be replicated. Sixty adults with oropharyngeal dysphagia secondary to OPSCC treatment will be enrolled in the study. This study will follow a cross over randomized design such that all participants will be provided with both types of treatment: using pen and paper (Treatment Arm A) and using the mobile health system (Treatment Arm B).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysphagia | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Swallowing exercise from home | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pen and Paper
- description
- Participants will complete swallowing exercises using printed materials and diary for tracking.
- interventionNames
- Other: Swallowing exercise from home
- type
- EXPERIMENTAL
- label
- Mobile health system
- description
- Participants will complete swallowing exercises using a mobile health system with surface electromyography (sEMG) biofeedback.
- interventionNames
- Other: Swallowing exercise from home
Primary outcomes (4)
- measure
- Percent adherence to recommended number of exercises
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * prior diagnosis of oropharyngeal dysphagia secondary to treatment for squamous cell carcinoma (OPSCC) * 3 months or later post-surgery or post-(chemo)radiation therapy * received treatment for head and neck cancer (e.g., +/-surgery, +/-radiation therapy, +/- chemotherapy) * attending speech-language pathologist has confirmed from a Modified Barium Swallow (MBS) assessment or Fiberoptic Endoscopic Evaluation of Swallowing (FEES) that the patient is a candidate for the effortful swallow and/or the Mendelsohn maneuver therapy. Exclusion Criteria: * have a history of cognitive delay (patient or SLP reported) * have a history of stroke or traumatic brain injury (patient or SLP reported) * cannot reliably navigate the Mobili-T system after the training session * attending SLP confirms planned swallowing exercises or procedures to address dysphagia like esophageal dilation * have an implanted electronic device of any kind, including cardiac pacemakers or similar assistive devices, electronic infusion pumps, and implanted stimulators * have irritated skin or skin with open wounds under the chin * have an allergy to silver * have a beard or not willing to shave or partially shave * unable to travel to Edmonton 3 times during a 3 month period
References
Publications (0)
Data not yet available