Status:

COMPLETED

Swallowing Therapy With the Assistance of a Mobile Health Device in Head and Neck Cancer Patients: a Pan-Alberta Study

Lead Sponsor:

University of Alberta

Collaborating Sponsors:

Alberta Cancer Foundation

Conditions:

Dysphagia

Head and Neck Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 swa...

Detailed Description

Background Dysphagia affects 22% of those over the age of 50 \[1\], which equates to 250 million people worldwide and 360,000 in Alberta \[2\]. At high risk are survivors of head and neck cancer (70%)...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

October 27 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2023

Estimated Enrollment :

18 Patients enrolled

Trial Details

Trial ID

NCT04698499

Start Date

October 27 2021

End Date

October 1 2023

Last Update

February 5 2024

Active Locations (1)

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1

University of Alberta

Edmonton, Alberta, Canada