CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
SleepStyle 200 Auto Series CPAP Humidifierdevice
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/NCT00750165
NCT00750165N/ACompleted

Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome.

Fisher and Paykel Healthcare·interventional·Posted Sep 10, 2008·Updated Apr 9, 2019

In Brief

A clinical study evaluating SleepStyle 200 Auto Series CPAP Humidifier for Sleep Apnea, Obstructive. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Nasal Continuous Positive Airway Pressure (CPAP) is the standard therapy for obstructive sleep apnea hypopnea syndrome (OSAHS). This is most commonly administered as a single positive pressure that has been individualized for the patient to prevent obstructive respiratory events. However, the therapeutic pressure may vary by sleep stage and body position within a single night and may change over the course of several nights. One approach to dealing with this variability is the use of automatically adjusting CPAP that responds to patient breathing patterns with alterations in the delivered pressure. This study is designed to determine the effectiveness of using the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables. Thirty subjects who require CPAP will be recruited from the NYU sleep disorders center. Following diagnostic studies (either split night or full night) the subject will undergo a night of treatment with the Fisher and Paykel Healthcare AutoPAP. Efficacy of treatment will be evaluated based on normalization of sleep disordered breathing while treated with the AutoPAP.

Study Details

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

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 10, 2008
Enrollment StartMay 1, 2007
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.8 years ago

Interventions

SleepStyle 200 Auto Series CPAP Humidifierdevice

The device is a standard CPAP machine with a built in computer controller that incorporates software for evaluation of the flow signal obtained from the CPAP machine