Status:
RECRUITING
Training Swallowing Initiation During Expiration
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Northwestern Memorial Hospital
Conditions:
Head and Neck Cancer
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 clinic...
Detailed Description
Head and neck cancers (HNC) have increased to epidemic levels in the United States. Despite good response to cancer treatment, survivors are suffering life-long toxicities that result in swallowing pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2027
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05278039
Start Date
May 19 2022
End Date
July 31 2027
Last Update
July 23 2025
Active Locations (2)
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1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
2
Northwestern University
Evanston, Illinois, United States, 60208