CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 156 enrolled
Drug / intervention
Continuous positive airway pressure +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00988351
NCT00988351N/ACompleted

Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA

North Florida Foundation for Research and Education·interventional·Posted Oct 2, 2009·Updated Nov 3, 2014

In Brief

A clinical study evaluating Continuous positive airway pressure and Auto-adjusting positive airway pressure treatment for Obstructive Sleep Apnea. Completed, enrolled 156 participants across 1 site.

Detailed Summary

The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2, 2009
Enrollment StartFeb 1, 2010
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.8 years ago

Interventions

Continuous positive airway pressuredevice

continuous positive airway pressure determined by polysomnography titration

Auto-adjusting positive airway pressure treatmentdevice

Pressure range 4-18 centimeters of water (cm H2O)