Neoplasms

All Conditions

Digestive System Diseases

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Deglutition Disorders

Esophageal Diseases

Gastrointestinal Diseases

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Participants will be trained to initiate swallowing during expiration.

Participants will practice swallowing, but will not learn the key therapeutic element (i.e., initiating swallowing during expiration).

Participants will complete 6 respiratory-swallow phase training sessions that will last approximately one hour.

Respiratory-Swallow Phase Training

Participants will complete 6 "swallow practice" sessions that will last approximately one hour.

Swallow Practice

Bonnie Martin-Harris, PhD

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.

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.

Participants and outcome assessors will be naive to experimental condition.

Training Swallowing Initiation During Expiration

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

Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer

Determines percent (frequency) of the target (expiratory phase) for each swallow.

Measures presence, depth and reaction to penetration and aspiration.

Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)

Measures physiologic swallowing impairment from observations of MBSS recordings

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University
Training Swallowing Initiation During Expiration	NCT05278039	Head and Neck C... Dysphagia Oropharyngeal D... Oropharynx Squa...	Respiratory-Swa... Swallow Practic...	18 Years -	Northwestern University

Spots Global Cancer Trial Database for swallow practice