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Validation of HC250 and HC240 Series.

This study has been completed.
Sponsor:
Information provided by:
Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier:
NCT00739011
First received: August 19, 2008
Last updated: December 7, 2008
Last verified: December 2008
History of Changes
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea (OSA)
 Device: SleepStyle 254/244 CPAP series CPAP humidifier

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Validation of Customer Requirements for the HC244/HC254

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Fisher and Paykel Healthcare:

Primary Outcome Measures:
  • Apnea Hypopnea Index (AHI) [ Time Frame: At the end of the sleep study ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739011

Locations
New Zealand
Auckland Physiology Sleep Lab
Auckland, New Zealand
Auckland Hospital Sleep laboratory
Auckland, New Zealand
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Principal Investigator: Jessica Hayward, MSc Fisher and Paykel Healthcare
  More Information

No publications provided

Responsible Party: Jessica Hayward, Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT00739011     History of Changes
Other Study ID Numbers: FPHC240/250Val
Study First Received: August 19, 2008
Last Updated: December 7, 2008
Health Authority: New Zealand: Health Research Council
New Zealand: Health and Disability Ethics Committees

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2013