Auto Continuous Positive Airway Pressure (CPAP) Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|---|---|
|
Sleep Apnea, Obstructive |
Device: SleepStyle 200 Auto Series CPAP Humidifier |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Auto CPAP Based Energy Spectrum Analysis of Flow for Treatment of Obstructive Sleep Apnea Hypopnea Syndrome. |
- Apnea Hypopnea Index (AHI) [ Time Frame: 1 night ] [ Designated as safety issue: No ]
- Oxygen saturation [ Time Frame: 1 Night ] [ Designated as safety issue: No ]
- Sleep Efficiency [ Time Frame: 1 Night ] [ Designated as safety issue: No ]
- Arousal Index (AI) [ Time Frame: 1 Night ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Treatment with the Fisher & Paykel Sleep Style 200 Auto CPAP device
|
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
Other Name: HC254
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- AHI >15 on the diagnostic portion of the study
- >18 years of age
Exclusion Criteria:
- Significant Central Apnea
- Congestive Heart Failure
- Inability to give informed consent
- Patient intolerance to CPAP
- Anatomical or physiological conditions making CPAP therapy inappropriate
Contacts and Locations| 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 |
More Information
Additional Information:
Publications:
| Responsible Party: | Jessica Hayward, Fisher & Paykel Healthcare |
| ClinicalTrials.gov Identifier: | NCT00750165 History of Changes |
| Other Study ID Numbers: | OSA CPAP; 254 Validation, NYU |
| Study First Received: | September 8, 2008 |
| Last Updated: | September 10, 2008 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Fisher and Paykel Healthcare:
|
Obstructive Sleep Apnea Humidification Continuous Positive Airway Pressure |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013