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Sponsored by: |
Fisher and Paykel Healthcare |
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Information provided by: | Fisher and Paykel Healthcare |
ClinicalTrials.gov Identifier: | NCT00750165 |
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.
Condition | Intervention | Phase |
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Sleep Apnea, Obstructive |
Device: SleepStyle 200 Auto Series CPAP Humidifier |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome. |
Enrollment: | 30 |
Study Start Date: | May 2007 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device
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Device: SleepStyle 200 Auto Series CPAP Humidifier
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
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
NYU Sleep Disorders Center | |
New York, New York, United States, 10016 |
Principal Investigator: | David M Rapoport, MD | NYU School of Medicine |
Responsible Party: | Fisher & Paykel Healthcare ( Jessica Hayward ) |
Study ID Numbers: | OSA CPAP; 254 Validation, NYU |
Study First Received: | September 8, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00750165 |
Health Authority: | United States: Institutional Review Board |
Obstructive Sleep Apnea Humidification Continuous Positive Airway Pressure |
Signs and Symptoms Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Signs and Symptoms, Respiratory Sleep Disorders, Intrinsic |
Nervous System Diseases |