RECRUITING

Training Swallowing Initiation During Expiration

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Head and neck cancers have escalated to epidemic levels in the United States, and survivors are suffering from life-long, devastating swallowing disorders with limited therapeutic options. This clinical trial investigates a novel swallowing treatment that trains initiation of swallowing during the expiratory phase of respiration to improve swallowing safety and efficiency.

Official Title

Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer

Quick Facts

Study Start:2022-05-19
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05278039

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of primary head and neck cancer
  2. * Three or more months post-completion of first-line cancer treatment
  3. * English speaking
  4. * Functional/corrected visual and hearing acuity
  5. * No current alcohol or other drug abuse
  6. * Without very severe (forced expiratory volume; FEV) 1 \<30% predicted) stage Chronic Obstructive Pulmonary Disease (COPD) based on Pulmonary Function Testing (PFT)
  7. * No skin allergy to the medical-grade sensor adhesive
  8. * Tolerate wearing the sensor for at least 10 hours/day
  9. * Tolerate some liquid oral intake on a routine basis
  10. * Normal dexterity to self-administer liquids via teaspoon
  11. * Initiation of swallowing during inspiratory phase of respiration on ≥20% of swallows
  12. * Penetration Aspiration Scale (PAS) score ≥3 or impairment on at least one MBSImP OI score (laryngeal vestibular closure ≥1, tongue base retraction ≥2, or pharyngeal residue ≥2) on at least one swallow during lateral view of MBSS
  13. * A PAS score of ≤6 on at least one liquid consistency without the use of a compensatory strategy or swallow maneuver
  1. * Persistent or recurrent cancer at the time of enrollment
  2. * Known allergy to contrast materials or liquids used during the MBSS or training
  3. * Known allergy to sensor adhesive
  4. * Unable to demonstrate competency with the user-friendly technology
  5. * Diagnosis of neurological disorders
  6. * Indwelling tracheostomy tube
  7. * Nasogastric (NG) feeding tube
  8. * History of aspiration pneumonia within the past 12 months
  9. * Unable to self-administer liquid boluses
  10. * Unable to swallow some liquids without a maneuver
  11. * Likely or currently pregnant

Contacts and Locations

Study Contact

Bonnie Martin-Harris, PhD
CONTACT
847-467-7447
scsc@northwestern.edu

Principal Investigator

Bonnie Martin-Harris, PhD
PRINCIPAL_INVESTIGATOR
Northwestern Memorial Hospital

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Northwestern University
Evanston, Illinois, 60208
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Bonnie Martin-Harris, PhD, PRINCIPAL_INVESTIGATOR, Northwestern Memorial Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-19
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2022-05-19
Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

  • Dysphagia
  • Swallowing Disorders
  • Swallowing Rehabilitation
  • Telehealth
  • Wearable Sensor
  • Respiratory-Swallow Coordination
  • Modified Barium Swallow Study

Additional Relevant MeSH Terms

  • Head and Neck Cancer
  • Dysphagia
  • Oropharyngeal Dysphagia
  • Oropharynx Squamous Cell Carcinoma