Validation of HC250 and HC240 Series.
|ClinicalTrials.gov Identifier: NCT00739011|
Recruitment Status : Completed
First Posted : August 21, 2008
Last Update Posted : December 9, 2008
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea (OSA)||Device: SleepStyle 254/244 CPAP series CPAP humidifier||Not Applicable|
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:
- Treatment with the HC254 Auto CPAP during the second half of the study.
- Treatment with the HC244 CPAP during the second half of the study.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Validation of Customer Requirements for the HC244/HC254|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
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
- Apnea Hypopnea Index (AHI) [ Time Frame: At the end of the sleep study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739011
|Auckland Hospital Sleep laboratory|
|Auckland, New Zealand|
|Auckland Physiology Sleep Lab|
|Auckland, New Zealand|
|Principal Investigator:||Jessica Hayward, MSc||Fisher and Paykel Healthcare|