Validation of HC250 and HC240 Series.
| Tracking Information | |||||
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| First Received Date ICMJE | August 19, 2008 | ||||
| Last Updated Date | December 7, 2008 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Apnea Hypopnea Index (AHI) [ Time Frame: At the end of the sleep study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00739011 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Validation of HC250 and HC240 Series. | ||||
| Official Title ICMJE | Validation of Customer Requirements for the HC244/HC254 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Obstructive Sleep Apnea (OSA) | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: 1
Intervention: Device: SleepStyle 254/244 CPAP series CPAP humidifier |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 40 | ||||
| Completion Date | November 2008 | ||||
| Primary Completion Date | November 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusions criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | New Zealand | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00739011 | ||||
| Other Study ID Numbers ICMJE | FPHC240/250Val | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jessica Hayward, Fisher and Paykel Healthcare | ||||
| Study Sponsor ICMJE | Fisher and Paykel Healthcare | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Fisher and Paykel Healthcare | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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