Clinical Trials Logo
  1. Home
  2. Oropharyngeal Dysphagia
  3. NCT03328702
  4. Details
NCT03328702 Clinical Trial

CPAP to Improve Swallow Function Post Total Laryngectomy

Oropharyngeal Dysphagia Clinical Trial

Official title:
Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03328702
Other study ID # 908521
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 27, 2016
Est. completion date November 8, 2022

Study information
Verified date May 2023
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Investigator initiated prospective study to determine whether use of Continuous Positive Airway Pressure (CPAP) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing

Description:

Total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. The procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. Following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. Previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. Continuous Positive Airway Pressure (CPAP) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. This study aims to evaluate the utility of a CPAP mask to improve pharyngeal swallow outcomes during Video Fluoroscopic Swallowing Exam (VFSE) in patients with dysphagia following total laryngectomy. This specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.

Recruitment information / eligibility
Status Completed
Enrollment 4
Est. completion date November 8, 2022
Est. primary completion date November 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients at least 2 months after total laryngectomy - Undergoing Video Fluoroscopic Swallowing Examination Exclusion Criteria: - Patients with 100% neopharyngeal stenosis - Patients with active cancer within 2 months of the study - Patients with pharyngocutaneous fistula - Vulnerable population: Adults unable to consent, Pregnant women, and Prisoners

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Continuous Positive Airway Pressure
Apex XT Fit CPAP Machine

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oropharyngeal and hypopharyngeal transit times During VFSE (1 day)
Secondary Pharyngeal Constriction Ratio (PCR) During VFSE (1 day)
See also
  Status Clinical Trial Phase
Completed NCT03284892 - Screening and Intervention of Postextubation Dysphagia N/A
Not yet recruiting NCT05958173 - Effects of 6-month of Treatment With TRPV1 and TRPA1 Agonists in Older Patients With OD N/A
Recruiting NCT04359199 - QUantitative Assessment of Swallowing After Radiation (QUASAR)
Terminated NCT03387267 - Videofluoroscopic Swallowing Study (VFSS) N/A
Recruiting NCT06250426 - Effect of a Cooling Sensation Flavor on the Swallow Response in Post-stroke Patients With Oropharyngeal Dysphagia N/A
Not yet recruiting NCT02874352 - Incidence of Dysphagia in Intensive Care Patients With Tracheostomy N/A
Recruiting NCT05720871 - Treatment of Chronic Post-stroke Oropharyngeal Dysphagia With Paired Stimulation N/A
Recruiting NCT04130867 - Rehabilitation Manometry Study
Completed NCT05405829 - Health Education to Caregivers to Reduce Aspiration Pneumonia N/A
Recruiting NCT05421689 - Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia Phase 1/Phase 2
Recruiting NCT02838316 - Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia Phase 1
Enrolling by invitation NCT05325658 - Influence of Modified Diet, Exercise and Electrical Swallowing Muscle Stimulation on Swallowing Function and Quality of Life in Elderly Patients With Oropharyngeal Dysphagia
Not yet recruiting NCT06368830 - Oral and Swallowing Function in Older Adults
Completed NCT02959450 - Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia N/A
Completed NCT02396992 - Minimal-Massive Intervention in Elderly Patients With Dysphagia N/A
Not yet recruiting NCT05862142 - A Predictive Model for Oropharyngeal Dysphagia in Non-hospitalized Older Patients
Recruiting NCT04581486 - Effectiveness of an Optimal-Massive Intervention in Older Patients With Dysphagia N/A
Terminated NCT01971320 - Evaluation of Transcutaneous Electrical Stimulation in Post Stroke Dysphagia Phase 3
Completed NCT01032928 - Respiratory-Swallow Training in Veterans With Oropharyngeal Cancer Phase 2
Completed NCT02170454 - Effect of Pharyngeal Inhibition by rTMS on Swallowing Function N/A

External Links