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| Sponsored by: |
Fisher and Paykel Healthcare |
|---|---|
| Information provided by: | Fisher and Paykel Healthcare |
| ClinicalTrials.gov Identifier: | NCT00739011 |
Purpose
This study is designed to determine the effectiveness of two different CPAP devices. One a standard CPAP which has the ability to store comprehensive compliance and efficacy data and the second a auto adjusting CPAP which uses the energy spectrum analysis of flow signals to automatically adjust CPAP pressure and improve sleep variables.
| Condition | Intervention |
|---|---|
|
Obstructive Sleep Apnea (OSA) |
Device: SleepStyle 254/244 CPAP series CPAP humidifier |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
| Official Title: | Validation of Customer Requirements for the HC244/HC254 |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Device: SleepStyle 254/244 CPAP series CPAP humidifier
Therapeutic CPAP pressure will be determined for individual subjects during the titration portion of an overnight sleep study. This pressure will range from 4 to 20 cmH20
|
All patients with suspected obstructive sleep apnea presenting at the Auckland Hospital Sleep Laboratory and referred for either a split-night or full night diagnostic study, will be offered participation in the study and will be recruited. From these patients, a total of 20 patients that are diagnosed with clinical obstructive sleep apnea syndrome, based on diagnostic polysomnography, will undergo titration with the HC254 Auto CPAP. An additional 20 patients will undergo titration with the HC244 CPAP. The sleep physiologist evaluating the patient clinically will approach patients for participation in this study during their sleep laboratory visit. Consenting patients will undergo either an initial full night diagnostic polysomnography or a split night study as determined by the physician based on clinical requirements. Patients diagnosed with obstructive sleep apnea (AHI > 15/hr) during this diagnostic component will then undergo one of the following:
The sleep physiologist will then determine final CPAP prescriptions for all patients based on the patient's response to CPAP therapy.
5 subjects who have completed the HC254 arm of the study will be brought back to the sleep lab for an additional PSG or partial PSG while on CPAP pressure set to 90th percentile pressure determined on the diagnostic night.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusions criteria:
Exclusion criteria:
Contacts and Locations| New Zealand | |
| Auckland Physiology Sleep Lab | |
| Auckland, New Zealand | |
| Auckland Hospital Sleep laboratory | |
| Auckland, New Zealand | |
| Principal Investigator: | Jessica Hayward, MSc | Fisher and Paykel Healthcare |
More Information
| Responsible Party: | Fisher and Paykel Healthcare ( Jessica Hayward ) |
| Study ID Numbers: | FPHC240/250Val |
| Study First Received: | August 19, 2008 |
| Last Updated: | December 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00739011 History of Changes |
| Health Authority: | New Zealand: Health Research Council; New Zealand: Health and Disability Ethics Committees |
|
Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Respiration Disorders |
Sleep Apnea, Obstructive Dyssomnias Sleep Disorders Sleep Disorders, Intrinsic |
|
Sleep Apnea Syndromes Respiratory Tract Diseases Apnea Nervous System Diseases Respiration Disorders |
Sleep Apnea, Obstructive Sleep Disorders Dyssomnias Sleep Disorders, Intrinsic |
