Training Swallowing Initiation During Expiration
Completed · Not applicable
Conditions studied: Head and Neck Cancer, Dysphagia, Oropharyngeal Dysphagia, Oropharynx Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05278039
- Run by
- Northwestern University
- People needed
- 88
- Starts
- 2022-05-19
- Expected to finish
- 2026-04-10
- Last updated by the study team
- 2026-05-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Northwestern Memorial Hospital — Chicago, Illinois, United States
- Northwestern University — Evanston, Illinois, United States
Full record on ClinicalTrials.gov
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