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Validation of HC250 and HC240 Series.

Primary Purpose

Obstructive Sleep Apnea (OSA)

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
SleepStyle 254/244 CPAP series CPAP humidifier
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Auckland Hospital Sleep laboratory
  • Auckland Physiology Sleep Lab

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index (AHI)

Secondary Outcome Measures

Full Information

First Posted
August 19, 2008
Last Updated
December 7, 2008
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT00739011
Brief Title
Validation of HC250 and HC240 Series.
Official Title
Validation of Customer Requirements for the HC244/HC254
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SleepStyle 254/244 CPAP series CPAP humidifier
Intervention Description
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 Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Time Frame
At the end of the sleep study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Hayward, MSc
Organizational Affiliation
Fisher and Paykel Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland Hospital Sleep laboratory
City
Auckland
Country
New Zealand
Facility Name
Auckland Physiology Sleep Lab
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

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Validation of HC250 and HC240 Series.

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