Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer (RSPT)
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|ClinicalTrials.gov Identifier: NCT01032928|
Recruitment Status : Completed
First Posted : December 16, 2009
Results First Posted : December 4, 2014
Last Update Posted : January 1, 2015
|Condition or disease||Intervention/treatment||Phase|
|Oropharyngeal Dysphagia Oropharyngeal Cancer||Behavioral: Respiratory-Swallow Phase training||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Respiratory Phase Training
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 [ 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 ]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 Impairment According to the Modified Barium Swallow Impairment Profile (MBSImP) [ 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 ]Analysis of the percentage of impaired swallow components using a dichotomized MBSImP scoring system
- Percentage of Impairment According to the Penetration-Aspiration Scale [ 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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01032928
|United States, South Carolina|
|Ralph H Johnson VA Medical Center, Charleston|
|Charleston, South Carolina, United States, 29401-5799|
|Principal Investigator:||Bonnie J Martin-Harris||Ralph H Johnson VA Medical Center, Charleston|