Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-26 @ 11:13 AM
NCT ID:
NCT01032928
Eligibility Criteria:
Inclusion Criteria:
* at least 21 years of age
* agreed to participate in this study and signed an informed consent, either completed by the participant or designated other
* have chronic impairments in oropharyngeal swallowing function following chemotherapy, radiation, and/or surgical intervention for the treatment of first time diagnosis of squamous cell carcinoma of the head and neck
* have completed medical treatments for his/her cancer and any traditional swallowing therapy at least 6 months earlier
* pass a cognitive screening (COGNISTAT)
* have at least one area of impairment (initiation of pharyngeal swallow, anterior hyolaryngeal excursion, extent and duration of PES opening, tongue base retraction, pharyngeal residue) as indicated by the results of the pre-intervention MBSImP (total sum MBSImP
* have PAS scores \>/= 3 on 10% of swallows on pre-intervention MBSS
* have a non-optimal (E-I, I-E, or I-I) breathing pattern on 60% of trial swallows.
Exclusion Criteria:
* known allergy or dietary restriction for food or contrast materials used during the exam
* evidence of persistent or recurrent disease on physical examination of the head and neck
* evidence of esophageal stricture noted on MBS
* recurrent oropharyngeal cancer and/or are being treated for other cancer(s) concurrently
* severe COPD (see Pulmonary Criteria below)
* nasogastric feeding tube
* recent change in swallowing status characterized by increase in perceived or observed -swallowing problems by patient, family or testing SLP
* any co-occurring neurological impairment affecting muscle strength and/or cognition
* history of aspiration pneumonia over the past 12 months.
* fail cognitive screening
* absence of swallowing impairment
* evidence of esophageal stricture on MBS
* inability to tolerate at least one of the liquid barium consistencies
* consistent optimal respiratory-swallow phase patterning
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT01032928
Study Brief:
Protocol Section:
NCT01032928