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Recruiting NCT05278039

Training Swallowing Initiation During Expiration

Trial Parameters

Condition Head and Neck Cancer
Sponsor Northwestern University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 88
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2022-05-19
Completion 2027-04-01
Interventions
Respiratory-Swallow Phase TrainingSwallow Practice

Brief 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 Criteria

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 consis

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