Training Swallowing Initiation During Expiration

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Dysphagia; Oropharyngeal Dysphagia; Oropharynx Squamous Cell Carcinoma
• Intervention / Treatment: Behavioral: Respiratory-Swallow Phase Training; Other: Swallow Practice

Detailed Description

Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing problems (dysphagia). Treatment options for dysphagia after HNC are extremely limited, focus on swallowing movements alone, and do not consider the importance of respiratory-swallow phase patterning. Prior evidence has demonstrated that when aberrant respiratory-swallow phase patterning is present (initiation of swallowing during inspiration) in patients with HNC, there is a higher occurrence of swallowing impairments, increased residue, and airway invasion. Further, it has been well established that the expiratory limb of the respiratory cycle provides a biomechanically advantageous set point in which to initiate safe and efficient swallowing. This randomized, controlled, Phase II clinical trial examines if respiratory-swallow phase training improves airway protection and swallowing efficiency in HNC survivors who are three or more months post-completion of first-line cancer treatment. The primary goal (Aim 1) is to determine if respiratory-swallow phase training results in increased frequency (%) of swallows initiated during expiration and improved swallowing safety. The secondary goal (Aim 2) is to examine the impact of respiratory-swallow phase training on the frequency of swallows initiated during expiration in wakeful, naturalistic swallowing environments, including eating and drinking. The investigators will recruit 88 HNC survivors with dysphagia, impaired respiratory-swallow phase patterning, and airway compromise. The investigators will deliver therapy remotely using a telehealth platform and an innovative wearable sensor that provides real-time visual feedback of respiratory-swallow movements. Endpoints will be measured from synchronized videofluoroscopic and respiratory-swallow sensor recordings at baseline, within 1-week post-treatment, and 1-month and 3-months post-treatment.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Respiratory-Swallow Phase Training; Participants will be trained to initiate swallowing during expiration.	Behavioral: Respiratory-Swallow Phase Training; Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.
Sham Comparator: Swallow Practice; Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).	Other: Swallow Practice; Participants will complete 6 "swallow practice" sessions that will last approximately one hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in frequency (%) of swallows initiated during expiration	Determines percent (frequency) of the target (expiratory phase) for each swallow.	Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
Change in Penetration-Aspiration Scale scores	Measures presence, depth and reaction to penetration and aspiration.	Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Normalized Residue Ratio Scale scores	Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)	Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 0 to 100% and higher scores indicate worse outcome.
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores	Measures physiologic swallowing impairment from observations of MBSS recordings	Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Oral Total scores range from 0-22 and Pharyngeal Total scores range from 0-26 and higher values indicate worse outcome.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in M.D. Anderson Dysphagia Inventory (MDADI) scores	Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer	Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 20 to 100 and higher scores indicate worse outcome.

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Northwestern Memorial Hospital
• Investigators: Principal Investigator: Bonnie Martin-Harris, PhD, Northwestern Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2022
• Primary Completion (Actual): April 10, 2026
• Study Completion (Actual): April 10, 2026

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dysphagia; Telehealth; Swallowing Disorders; Swallowing Rehabilitation; Wearable Sensor; Respiratory-Swallow Coordination; Modified Barium Swallow Study
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Glandular and Epithelial; Esophageal Diseases; Carcinoma; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Deglutition Disorders
• Other Study ID Numbers: R01CA262502 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No