CPAP to Improve Swallow Function Post Total Laryngectomy

NCT03328702 | Completed Results FDA Device

• 1 other identifier: 908521
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Oropharyngeal Dysphagia; Laryngectomy; Status

Keywords

Dysphagia; Oropharyngeal dysphagia; Total Laryngectomy; Video Fluoroscopic Swallowing Exam (VFSE)

Outcome Measures

Primary Outcomes (1)

• Total Pharyngeal Transit Time (With CPAP)

  This is the time in seconds that it takes for a bolus to move from the oral cavity, through the pharynx, and into the so. It is measured in seconds and is the primary outcome measure.

  During VFSE (1 day)

Study Arms (1)

Continue Positive Airway Pressure

EXPERIMENTAL

Continue Positive Airway Pressure during VFSE

Device: Continuous Positive Airway Pressure

Interventions

Continuous Positive Airway Pressure DEVICE

Apex XT Fit CPAP Machine

Continue Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 2 months after total laryngectomy
• Undergoing Video Fluoroscopic Swallowing Examination

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Related Links

• Learn more or sign up for the study here!

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Peter Belafsky
• Organization: University of California, Davis

pcbelafsky@ucdavis.edu

8582053366

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 1, 2017
• Study Start: June 27, 2016
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-12

Locations

US (1)