Training Swallowing Initiation During Expiration

Sponsor

Northwestern University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05278039

Collaborator

Northwestern Memorial Hospital (Other)

Enrollment

Locations

Arms

50.4

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Oropharyngeal 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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Dysphagia Oropharyngeal Dysphagia Oropharynx Squamous Cell Carcinoma	Behavioral: Respiratory-Swallow Phase Training Other: Swallow Practice	N/A

Detailed Description

Oropharyngeal head and neck cancers (OP 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 OP 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 OP 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 OP 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 OP 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 Design

Study Type:

Interventional

Anticipated Enrollment :

88 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized-controlled trialRandomized-controlled trial

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Participants and outcome assessors will be naive to experimental condition.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 19, 2022

Anticipated Primary Completion Date :

Apr 1, 2026

Anticipated Study Completion Date :

Jul 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in frequency (%) of swallows initiated during expiration [Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.]
Determines percent (frequency) of the target (expiratory phase) for each swallow.
Change in Penetration-Aspiration Scale scores [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.]
Measures presence, depth and reaction to penetration and aspiration.

Secondary Outcome Measures

Change in Normalized Residue Ratio Scale scores [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.]
Quantifies pharyngeal space residue obtained in the lateral view during Modified Barium Swallow Study (MBSS)
Change in Modified Barium Swallow Impairment Profile (MBSImP) scores [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.]
Measures physiologic swallowing impairment from observations of MBSS recordings

Other Outcome Measures

Change in M.D. Anderson Dysphagia Inventory (MDADI) scores [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.]
Evaluates the impact of dysphagia on the quality of life of patients with head and neck cancer

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

New diagnosis of primary oropharyngeal head and neck cancer
Within 3-6 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
Non-smoking
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 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