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CPAP Device In-lab Assessment NZ

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Auto CPAP + comfort feature A
Auto CPAP with comfort feature B
Auto CPAP with no comfort feature
Auto CPAP with comfort feature A+B
CPAP with comfort feature A
CPAP with comfort feature B
CPAP with no comfort feature
CPAP with comfort feature A + B
CPAP at Sub therapeutic level
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

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years or older
  • Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
  • Fluent in spoken and written English.

Exclusion Criteria:

  • Be contraindicated for PAP (fixed or auto CPAP) therapy.
  • Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
  • Have obesity hypoventilation syndrome or congestive heart failure.
  • Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
  • Have any implanted electronic medical devices (e.g. cardiac pacemakers).
  • Be pregnant or think they might be pregnant.

Sites / Locations

  • Fisher & Paykel Healthcare

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Auto CPAP + comfort feature A

Auto CPAP with comfort feature B

Auto CPAP with no comfort feature

Auto CPAP with comfort feature A+B

CPAP with comfort feature A

CPAP with comfort feature B

CPAP with no comfort feature

CPAP with comfort feature A + B

CPAP at Sub therapeutic level

Arm Description

Auto CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device

Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device

Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device

Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device

CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device

CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device

CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device

CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device

CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
Obtained from device and PSG data
Log of safety-related events, measured as number of safety-related faults
Obtained from device
Machine reported faults, measured as number of machine faults
Obtained from device

Secondary Outcome Measures

Participant perception of the device, as determined by the questionnaire responses
Obtained through user questionnaire

Full Information

First Posted
October 26, 2016
Last Updated
June 26, 2017
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02948010
Brief Title
CPAP Device In-lab Assessment NZ
Official Title
CPAP Device In-lab Assessment NZ
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements
Detailed Description
Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auto CPAP + comfort feature A
Arm Type
Active Comparator
Arm Description
Auto CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
Arm Title
Auto CPAP with comfort feature B
Arm Type
Active Comparator
Arm Description
Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Arm Title
Auto CPAP with no comfort feature
Arm Type
Active Comparator
Arm Description
Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Arm Title
Auto CPAP with comfort feature A+B
Arm Type
Active Comparator
Arm Description
Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
Arm Title
CPAP with comfort feature A
Arm Type
Active Comparator
Arm Description
CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
Arm Title
CPAP with comfort feature B
Arm Type
Active Comparator
Arm Description
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Arm Title
CPAP with no comfort feature
Arm Type
Active Comparator
Arm Description
CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Arm Title
CPAP with comfort feature A + B
Arm Type
Active Comparator
Arm Description
CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
Arm Title
CPAP at Sub therapeutic level
Arm Type
Active Comparator
Arm Description
CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
Auto CPAP + comfort feature A
Intervention Description
Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
Auto CPAP with comfort feature B
Intervention Description
Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
Auto CPAP with no comfort feature
Intervention Description
Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
Auto CPAP with comfort feature A+B
Intervention Description
Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
CPAP with comfort feature A
Intervention Description
CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
CPAP with comfort feature B
Intervention Description
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
CPAP with no comfort feature
Intervention Description
CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
CPAP with comfort feature A + B
Intervention Description
CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
Intervention Type
Device
Intervention Name(s)
CPAP at Sub therapeutic level
Intervention Description
CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
Description
Obtained from device and PSG data
Time Frame
4 months
Title
Log of safety-related events, measured as number of safety-related faults
Description
Obtained from device
Time Frame
4 months
Title
Machine reported faults, measured as number of machine faults
Description
Obtained from device
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Participant perception of the device, as determined by the questionnaire responses
Description
Obtained through user questionnaire
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP) Fluent in spoken and written English. Exclusion Criteria: Be contraindicated for PAP (fixed or auto CPAP) therapy. Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia). Have obesity hypoventilation syndrome or congestive heart failure. Require supplemental oxygen with your PAP (fixed or auto CPAP) device. Have any implanted electronic medical devices (e.g. cardiac pacemakers). Be pregnant or think they might be pregnant.
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No

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CPAP Device In-lab Assessment NZ

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