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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

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
Bonnie Martin-Harris, PhD847-467-7447scsc@northwestern.edu
Northwestern University
Evanston, Illinois, 60208
Bonnie Martin-Harris, PhD847-467-7447scsc@northwestern.edu

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