NCT05278039Completed
Training Swallowing Initiation During Expiration
Training Swallowing Initiation During Expiration: Impact on Safety and Efficiency Following Treatment for Oropharyngeal Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 88 (actual)
- First submitted
- 8 Feb 2022
- Start date
- 19 May 2022
- Primary completion date
- 10 Apr 2026
- Lead sponsor
- Northwestern University
- Diseases
- Head and neck cancer
- NCT number
- NCT05278039
What you commit to
- Study type: Interventional
- Participants enrolled: 88
- From 19 May 2022 to the primary completion date, 10 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Diagnosis of neurological disorders
- History of aspiration pneumonia within the past 12 months
Other
- Unable to demonstrate competency with the user-friendly technology
- Indwelling tracheostomy tube
- Nasogastric (NG) feeding tube
- Unable to self-administer liquid boluses
- Unable to swallow some liquids without a maneuver
- Likely or currently pregnant
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern Memorial Hospital Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Evanston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.