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Determination of Upper Airway Collapsibility During Routine CPAP Titration

NCT02566278 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-07-10

No results posted yet for this study

Summary

The investigators hypothesis is that upper airway collapsibility (Pcrit) in patients with obstructive sleep apnea (OSA) can be measured using equipment found in the clinical sleep laboratory and these Pcrit measurements obtained using clinical sleep laboratory equipment is comparable to those obtained using research equipment. OSA is a common disease characterized by repetitive collapse of the upper airway during sleep, leading to hypoxemia and arousals, and which has important neurocognitive and cardiovascular consequences. The single most important factor in the development of OSA is upper airway collapsibility: those with a more collapsible upper airway tend to have OSA while those with a stiffer upper airway do not. The gold standard treatment for OSA is continuous positive airway pressure (CPAP), which acts by stenting open the collapsible airway. Upper airway collapsibility can be measured during sleep by changing the CPAP level and assessing the change in inspiratory flow through the upper airway. Although technically feasible, these measurements are typically only undertaken in research laboratories with specialized equipment. The purpose of this study is to measure upper airway collapsibility using clinically available (i.e. equipment found in a clinical sleep laboratory) equipment only. If successful, upper airway collapsibility could be routinely measured in clinical practice, which could help inform treatment decisions and help individualize therapy for OSA.

Conditions

Interventions

OTHER

Upper airway collapsibility (Pcrit)

To measure passive Pcrit, patients sleep with a mask over their nose or nose and mouth, and CPAP is applied using a custom made machine that can rapidly change mask pressures in research setting. The idea is that rapid changes in airway pressure produce a clear step change in airflow that will be observed quickly. In contrast, during clinical titrations, the CPAP machines change pressure much more slowly to help promote patient comfort. Passive Pcrit will be measured using both research and clinical equipment in the same patients and the Pcrit result using clinical CPAP titration equipment will be compared to the gold standard: Pcrit measurement done through research equipment that changes CPAP pressure rapidly.

Sponsors & Collaborators

Principal Investigators

  • Robert Owens, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-20
Primary Completion
2016-07-25
Completion
2016-07-25

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02566278 on ClinicalTrials.gov