Validation of HC250 and HC240 Series.

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

Validation of Customer Requirements for the HC244/HC254

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739011
• Other study ID #: FPHC240/250Val
• Status: Completed
• Phase: N/A
• First received: August 19, 2008
• Last updated: December 7, 2008
• Start date: August 2008
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health Research CouncilNew Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusions criteria:

• AHI > 15 on the diagnostic night or portion of the split night study.

• =18yrs of age

Exclusion criteria:

• Significant Central Apnea

• CHF

• Co-existing obesity related hypoventilation

• Inability to give informed consent

• Patient intolerance to CPAP

• Anatomical or physiological conditions making CPAP therapy inappropriate.

• Less than 3 hours in the titration period

• Under Land Transport New Zealand (LTNZ) investigation

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea (OSA)
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
New Zealand	Auckland Hospital Sleep laboratory	Auckland
New Zealand	Auckland Physiology Sleep Lab	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI)		At the end of the sleep study	No