Training Swallowing Initiation During Expiration (NCT05278039) | Clinical Trial Compass
CompletedNot Applicable
Training Swallowing Initiation During Expiration
United States88 participantsStarted 2022-05-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in frequency (%) of swallows initiated during expiration
Timeframe: Change from baseline to 1-week post-treatment and 2-4-6-8-10-12-weeks post-treatment.
2
Change in Penetration-Aspiration Scale scores
Timeframe: Change from baseline to 1-week post-treatment, 1-month post-treatment, and 3-months post treatment. Scores range from 1-8 and higher scores indicate worse outcome.