CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Manipulation of Positive Airway Pressure (PAP)other
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/NCT01175031
NCT01175031N/ACompleted
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Validation of Breathing Event Detection of the Philips Respironics Sleep Therapy System REMstar Auto A-Flex Compared to Clinical Polysomnography

Philips Respironics·interventional·Posted Aug 4, 2010·Updated Oct 31, 2018

In Brief

A clinical study evaluating Manipulation of Positive Airway Pressure (PAP) for Sleep Apnea Central and 2 related conditions. Completed, enrolled 45 participants across 3 sites.

Detailed Summary

The purpose of this study is to demonstrate diagnostic agreement and determine the accuracy of the continuous positive airway pressure (CPAP) device compared to simultaneous, attended clinical polysomnography (PSG) in identifying breathing events in participants previously diagnosed with complex sleep apnea (CompSAS), complex sleep apnea with Cheyne-Stokes respiration (CSR), or obstructive sleep apnea (OSA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea Central, Cheyne-Stokes Respiration, Obstructive Sleep Apnea
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 4, 2010
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2013
Study CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.9 years ago

Interventions

Manipulation of Positive Airway Pressure (PAP)other

Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.