Training Swallowing Initiation During Expiration

Study Overview
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Brief Summary
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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.

Detailed Description
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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 in the subacute phase (3-6 mo.) of recovery. 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.

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

Conditions
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Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia, Oropharynx Squamous Cell Carcinoma

Intervention / Treatment
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* Behavioral: Respiratory-Swallow Phase Training
* Other: Swallow Practice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of primary head and neck cancer Three or more months post-completion of first-line cancer treatment Pass cognitive screen (score ≥26 on Montreal Cognitive Assessment) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized-controlled trial
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Swallowing Disorders, Swallowing Rehabilitation, Telehealth, Wearable Sensor, Respiratory-Swallow Coordination, Modified Barium Swallow Study