At a glance
ClinicalIndex Comparison RecordN/ACompleted· 115 enrolled
Drug / intervention
Analysis with AED and manual PSG scoringdevice
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.
Validation of Breathing Event Detection of the REMstar Auto With Aflex Compared to Clinical Polysomnography
In Brief
A clinical study evaluating Analysis with AED and manual PSG scoring for Sleep Apnea. Completed, enrolled 115 participants across 1 site.
Detailed Summary
The study is to compare the performance of a CPAP (continuous positive airway pressure) device to a clinical polysomnography (PSG) in identifying breathing events in patients with obstructive sleep apnea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2009
First PostedFeb 2009
Primary CompletionAug 2009
TodayJul 2026
First PostedFeb 4, 2009
Enrollment StartFeb 1, 2009
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 17.4 years ago
Interventions
Analysis with AED and manual PSG scoringdevice
The CPAP device will be set-up at a sub-therapeutic pressure and will remain at this pressure for the entire night, if tolerated. Then the events will be analyzed with Automatic Event Detection (AED) and manual PSG scoring.