A Phase 2 interventional study of Respiratory-Swallow Phase training in Oropharyngeal Dysphagia and Oropharyngeal Cancer, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2015-01-01.
Sponsored by US Department of Veterans Affairs · Phase 2, Interventional, and Treatment
Cancers of the head and neck require surgical, radiation, and chemotherapy treatments that are intended to cure the disease. These treatments have toxic effects on muscles and structures that are necessary to swallow safely and efficiently. The resulting swallowing problems (dysphagia) often remain chronic for Veterans and interfere with their ability to eat and drink. The cost burden to the VA health system is high. There is an urgent need to develop rehabilitative treatments that lessen these burdens. The proposed research is designed to test a novel swallowing therapy that includes the coordination of breathing with swallowing. Our study will train medically and surgically treated, chronically dysphagic Veterans with histories of oropharyngeal cancer in a novel therapy that involves both swallowing and respiratory systems. If the therapy is found to be effective, the long term goal of the project is to extend the study to a multi-site, clinical trial and test the longstanding effect of this treatment compared to other swallowing therapies on swallowing function, QOL and cost.
Swallowing impairments (dysphagia) represent the highest functional morbidity in veteran patients treated for oropharyngeal cancers with either surgical approaches followed by radiation or with more recent organ-preservation protocols. The nature of the impairments is often resistive to treatment and results in life-long health consequences and high cost burden on the VA health system. Recent preliminary data have linked alterations in the otherwise highly stable respiratory-swallowing phase pattern relationships to the swallowing impairment and penetration/aspiration and in this patient group. The immediate goal of this clinical trial is to test the effect of a novel respiratory-swallow intervention on swallowing impairment and penetration/aspiration in a cohort of chronically dysphagic veterans following treatment for oropharyngeal cancer. Patients presenting with a "non-optimal" respiratory-swallow phase pattern during liquid swallows and measurable swallowing impairment will learn an "optimal" physiologic pattern that facilitates both airway protective and mechanical advantages during swallowing. The broad goal of this research is to develop ideal respiratory-swallowing phase training methods and regimens that alone or combined with traditional swallowing treatments improve swallowing function in the acute phases of recovery and improve long term patient outcome. Our intention is to use these preliminary data to motivate a larger clinical trial to compare the effect of respiratory-swallow phase training with other evidenced based methods of swallowing treatment and expand the approach to other patient groups that have indications of respiratory-swallow phase impairments (e.g. pulmonary disease and stroke) contributing to impaired swallowing function
723 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 482 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →US Department of Veterans Affairs is the lead sponsor of 675 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns participated in up to 8 sessions of respiratory phase training to learn an optimal respiratory - swallow phase pattern
Behavioral: Respiratory-Swallow Phase training
Patients were presented with visually guided respiratory feedback to train optimal respiratory-swallow coordination patterns.
Optimal Respiratory - Swallow Phase
Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).
Time frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
Percentage of Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP)
Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
Time frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
Percentage of Impairment According to the Penetration-Aspiration Scale
The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores \< 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.
Time frame: Patient were assessed pre-treatment, one week post treatment and one month post treatment. Treatment sessions were twice weekly for up to 4 weeks
Participants were recruited from the Head and Neck Clinics at the Ralph H Johnson Veterans Administration Medical Center and the Medical University of South Carolina between May 2010 and April 2013
| Milestone | Respiratory - Swallow Phase Training |
|---|---|
| Started | 30 |
| Completed | 30 |
| Not completed | 0 |
Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
| percentage of impairment | Pre-intervention | One Week Post Intervention | One Month Post Intervention |
|---|---|---|---|
| Lip closure | 5.7 | 9.3 | 2.8 |
| Tongue control | 58.7 | 53.8 | 59.2 |
| Bolus transport | 37.3 | 50.2 | 41.5 |
| Oral residue | 77.3 | 76.4 | 71.1 |
| Initiation of pharyngeal swallow | 90.4 | 90.8 | 91.1 |
| Soft palate elevation | 19.8 | 31.0 | 15.6 |
| laryngeal elevation | 76.6 | 70.8 | 63.3 |
| Anterior hyiod excursion | 94.7 | 90.5 | 93.3 |
| Epiglottic inversion | 71.9 | 68.3 | 55.6 |
| Laryngeal vestibular closure | 78.2 | 55.5 | 62.2 |
| Pharyngeal stripping wave | 59.3 | 67.6 | 60.7 |
| Pharyngoesophageal segment opening | 80.6 | 80.5 | 70.0 |
| Tongue base retraction | 96.0 | 88.6 | 80.7 |
| Pharyngeal residue | 96.1 | 88.4 | 83.0 |
The penetration aspiration scale is a validated 8 point interval scale used to describe penetration and aspiration events. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled. Scores \< 3 are considered to be normal. For the purpose of our study scores were dichotimized to normal and impaired.
| percentage of swallows with impaired PAS | Pre-intervention | One Week Post Intervention | One Month Post Intervention |
|---|---|---|---|
| Percentage of Impairment According to the Penetration-Aspiration Scale | 78.0 | 38.3 | 42.2 |
Respiratory swallow patterns were collected using nasal airflow and respiratory inductance plethysmography (RIP) of each swallow during the modified barium swallow study. The movements of the ribcage and abdomen were recorded using RIP; data synchronized and recorded using the KayPentax Digital Swallow Workstation Signals Lab. Subjects were categorized as optimal (expiratory-expiratory) versus non-optimal (non-expiratory-expiratory).
| percentage of swallows | Pre-intervention | One Week Post-intervention | One Month Post Intervention |
|---|---|---|---|
| Optimal Respiratory - Swallow Phase | 43 | 86 | 88.1 |
Collected over Duration of the study. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | — | 0/30 (0%) | 0/30 (0%) |
Entire Enrolled Study Population
| Age, Categorical(Participants) | Respiratory-Swallow Phase Training |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 17 |
| >=65 years | 13 |
| Age, Continuous(years) | Respiratory-Swallow Phase Training |
|---|---|
| Mean | 61 ± 11 |
| Sex: Female, Male(Participants) | Respiratory-Swallow Phase Training |
|---|---|
| Female | 4 |
| Male | 26 |
| Ethnicity (NIH/OMB)(Participants) | Respiratory-Swallow Phase Training |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 30 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Respiratory-Swallow Phase Training |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 4 |
| White | 26 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Respiratory-Swallow Phase Training |
|---|---|
| United States | 30 |
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
US Department of Veterans Affairs →