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Training Swallowing Initiation During Expiration
RECRUITINGN/ASponsored by Northwestern University
Actively Recruiting
PhaseN/A
SponsorNorthwestern University
Started2022-05-19
Est. completion2027-04-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05278039
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions5
CancerDysphagiaHead and Neck CancerOropharyngeal DysphagiaOropharynx Squamous Cell Carcinoma
Locations2 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northwestern University
Evanston, Illinois, 60208
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Actively Recruiting
PhaseN/A
SponsorNorthwestern University
Started2022-05-19
Est. completion2027-04-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT05278039