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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Illinois
Northwestern Memorial Hospital
RECRUITING
Chicago
Northwestern University
RECRUITING
Evanston
Contact Information
Primary
Bonnie Martin-Harris, PhD
scsc@northwestern.edu
847-467-7447
Time Frame
Start Date: 2022-05-19
Estimated Completion Date: 2027-07-31
Participants
Target number of participants: 88
Treatments
Experimental: Respiratory-Swallow Phase Training
Participants will be trained to initiate swallowing during expiration.
Sham_comparator: Swallow Practice
Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).
Sponsors
Collaborators: Northwestern Memorial Hospital
Leads: Northwestern University

This content was sourced from clinicaltrials.gov