Continuous Positive Airway Pressure for Oropharyngeal Dysphagia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Oropharyngeal Dysphagia+1 MoreContinuous Positive Airway Pressure - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test whether CPAP can help patients who had a total laryngectomy and are having trouble swallowing.

Eligible Conditions
  • Oropharyngeal Dysphagia
  • Laryngectomy

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: During VFSE (1 day)

During VFSE (1 day)
Oropharyngeal and hypopharyngeal transit times
Pharyngeal Constriction Ratio (PCR)

Trial Safety

Side Effects for

Laparoscopic Gastric Banding
32%Respiratory tract infections
21%Drowsy driving
18%Injuries NEC
14%Epidermal and dermal conditions
14%Aural disorders NEC
11%Gastrointestinal signs and symptoms
11%Joint disorders
7%Tendon, ligament and cartilage disorders
7%Respiratory disorders NEC
7%Headaches
7%Gallbladder disorders
7%Female reproductive tract infections and inflammations
7%Upper respiratory tract disorders (excl infections)
4%Skin and subcutaneous tissue infections and infestations
4%Ocular infections, irritations and inflammations
4%Gastrointestinal motility
4%Mood disorders and disturbances NEC
4%Gastrointestinal infections
4%Bone and joint injuries
4%Urinary tract signs and symptoms
4%Coronary artery disrders
4%Anxiety disorders and symptoms
4%Suicidal and self-injurious behaviors NEC
4%Bone disorders (excl congenital and fractures)
4%Diverticular disorders
4%Medication errors
4%Procedural related injuries and complicatins NEC
4%Musculoskeletal and connective tissue disorders NEC
4%Glucose metabolism disorders
4%Muscle disorders
4%Depressed mood disorders and disturbances
4%Demyelinating disorders
4%Genitourinary tract disorders NEC
This histogram enumerates side effects from a completed 2014 Phase 2 trial (NCT01187771) in the Laparoscopic Gastric Banding ARM group. Side effects include: Respiratory tract infections with 32%, Drowsy driving with 21%, Injuries NEC with 18%, Epidermal and dermal conditions with 14%, Aural disorders NEC with 14%.

Trial Design

1 Treatment Group

Continue Positive Airway Pressure
1 of 1

Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Continuous Positive Airway Pressure · No Placebo Group · N/A

Continue Positive Airway Pressure
Device
Experimental Group · 1 Intervention: Continuous Positive Airway Pressure · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous Positive Airway Pressure
2016
Completed Phase 3
~1350

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: during vfse (1 day)

Who is running the clinical trial?

University of California, DavisLead Sponsor
844 Previous Clinical Trials
5,014,341 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
showed a decline in their health-related quality of life Laryngectomy patients showed a decline in their quality of life related to their health after 2 months.