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OpenTrials
Completed

NCT Number: NCT00739011

Validation of HC250 and HC240 Series.

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Auckland Hospital Sleep laboratory, Auckland, New Zealand

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SleepStyle 254/244 CPAP series CPAP humidifier

Device

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

Primary outcomes

  1. Apnea Hypopnea Index (AHI)

    Time frame: At the end of the sleep study

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

Validation of Customer Requirements for the HC244/HC254

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Aug 21, 2008
Registry last updated
Dec 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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