Oropharyngeal DysphagiaNCT03328702
CPAP to Improve Swallow Function Post Total Laryngectomy
A study testing Continuous Positive Airway Pressure in people with Oropharyngeal Dysphagia and Laryngectomy; Status, run by University of California, Davis at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia, Laryngectomy; Status
- What is being tested?
- Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2016to 8 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients at least 2 months after total laryngectomy
- Undergoing Video Fluoroscopic Swallowing Examination
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy
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
Read the detailed 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.
- Conditions
- Oropharyngeal Dysphagia, Laryngectomy; Status
- Being tested
- Continuous Positive Airway Pressure
- Keywords
- Dysphagia, Oropharyngeal dysphagia, Total Laryngectomy, Video Fluoroscopic Swallowing Exam (VFSE)
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway PressureDevice
Apex XT Fit CPAP Machine
| Study group | Role | What they receive |
|---|---|---|
| Continue Positive Airway Pressure | Experimental | Continue Positive Airway Pressure during VFSE Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During VFSE (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start27 Jun 2016
- Primary completion8 Nov 2022
- Study completion8 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328702
- Sponsor's protocol ID
- 908521
- Status last verified
- Dec 2024
- First submitted
- 29 Oct 2017
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Continuous Positive Airway Pressure to Improve Swallow Function in Patients Post Total Laryngectomy
- ClinicalTrials.gov ID
- NCT03328702
- Acronym / sponsor ID
- 908521
- Conditions
- Oropharyngeal Dysphagia, Laryngectomy; Status
- Keywords
- Dysphagia, Oropharyngeal dysphagia, Total Laryngectomy, Video Fluoroscopic Swallowing Exam (VFSE)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 27 Jun 2016 (actual)
- Primary completion
- 8 Nov 2022 (actual)
- Study completion
- 8 Nov 2022 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continue Positive Airway Pressure | Experimental | Device: Continuous Positive Airway PressureContinue Positive Airway Pressure during VFSE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients at least 2 months after total laryngectomy
- Undergoing Video Fluoroscopic Swallowing Examination
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous Positive Airway PressureApex XT Fit CPAP Machine | Device | Continue Positive Airway Pressure |
Primary outcome
Total Pharyngeal Transit Time (With CPAP)
Time frame: During VFSE (1 day)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Learn more or sign up for the study here!Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure in people with Oropharyngeal Dysphagia and Laryngectomy; Status, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Pharyngeal Transit Time (With CPAP) (time frame: During VFSE (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.