Validation of HC250 and HC240 Series.

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Device: SleepStyle 254/244 CPAP series CPAP humidifier

• Registration Number: NCT00739011
• Lead Sponsor: Fisher and Paykel Healthcare

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.

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:

* 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 Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-21
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2008-12
• Last Update Submitted: 2008-12-07
• Last Update Posted: 2008-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	SleepStyle 254/244 CPAP series CPAP humidifier	-

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index (AHI)	At the end of the sleep study

Trial Locations

Locations (2)

Auckland Hospital Sleep laboratory; 🇳🇿 Auckland, New Zealand

Auckland Physiology Sleep Lab; 🇳🇿 Auckland, New Zealand