Training Swallowing Initiation During Expiration

Launched by NORTHWESTERN UNIVERSITY · Mar 3, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to help people who have trouble swallowing due to head and neck cancer. Many survivors of these cancers experience significant swallowing difficulties, which can greatly affect their quality of life. The trial is testing a treatment that teaches patients to start swallowing when they breathe out, which may make swallowing safer and more efficient.

To participate in this trial, you need to have been diagnosed with head and neck cancer and have completed your initial treatment at least three months ago. You should be able to speak English and have good vision and hearing. Participants must also be able to tolerate wearing a small sensor for about 10 hours a day and should be able to swallow some liquids without much difficulty. During the trial, you can expect to receive training on this new swallowing technique. It’s a chance to be part of important research that could lead to better treatments for swallowing problems in cancer survivors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of primary head and neck cancer
• • Three or more months post-completion of first-line cancer treatment
• • English speaking
• • Functional/corrected visual and hearing acuity
• • No current alcohol or other drug abuse
• • Without very severe (forced expiratory volume; FEV) 1 \<30% predicted) stage Chronic Obstructive Pulmonary Disease (COPD) based on Pulmonary Function Testing (PFT)
• • No skin allergy to the medical-grade sensor adhesive
• • Tolerate wearing the sensor for at least 10 hours/day
• • Tolerate some liquid oral intake on a routine basis
• • Normal dexterity to self-administer liquids via teaspoon
• • Initiation of swallowing during inspiratory phase of respiration on ≥20% of swallows
• • 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
• • A PAS score of ≤6 on at least one liquid consistency without the use of a compensatory strategy or swallow maneuver
• Exclusion Criteria:
• • Persistent or recurrent cancer at the time of enrollment
• • Known allergy to contrast materials or liquids used during the MBSS or training
• • Known allergy to sensor adhesive
• • Unable to demonstrate competency with the user-friendly technology
• • Diagnosis of neurological disorders
• • Indwelling tracheostomy tube
• • Nasogastric (NG) feeding tube
• • History of aspiration pneumonia within the past 12 months
• • Unable to self-administer liquid boluses
• • Unable to swallow some liquids without a maneuver
• • Likely or currently pregnant