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Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Terminated
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake Off + Pressure Support B
Competitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support B
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:

  • Aged 18 and over
  • Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP.
  • For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator)

Exclusion Criteria:

  • Contraindicated for PAP (CPAP or AutoCPAP) therapy
  • Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)
  • Persons with obesity hypoventilation syndrome or congestive heart failure.
  • Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device
  • Persons with implanted electronic medical device (e.g cardiac pacemakers)
  • Persons who are pregnant or think they might be pregnant.

Sites / Locations

  • Fisher & Paykel Healthcare
  • WellSleep Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

FPH Device with SensAwake On + Pressure Support A

FPH Device with SensAwake Off + Pressure Support A

FPH Device with SensAwake On + Pressure Support B

FPH Device with SensAwake Off + Pressure Support B

Competitor's PAP Released Device + Pressure Support A

Competitor's PAP Released Device + Pressure Support B

Arm Description

FPH Device with SensAwake On + Pressure Support A

FPH Device with SensAwake Off + Pressure Support A

FPH Device with SensAwake On + Pressure Support B

FPH Device with SensAwake Off + Pressure Support B

Competitor's PAP Released Device + Pressure Support A

Competitor's PAP Released Device + Pressure Support B

Outcomes

Primary Outcome Measures

Apnea Hypopnea Index (AHI)
Through the device and independent flow logger
Apnea Hypopnea Index (AHI)
Through the polysomnography

Secondary Outcome Measures

Therapy Comfort
Through a subjective questionnaire
Compliance
Through the device and independent flow logger
Device Triggering
Through the device
Device Triggering
Through the polysomnography

Full Information

First Posted
November 17, 2016
Last Updated
August 1, 2018
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02971436
Brief Title
Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Why Stopped
project progression decision was able to be made with the data already gathered
Study Start Date
December 2016 (undefined)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 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
This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.

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
Participant
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FPH Device with SensAwake On + Pressure Support A
Arm Type
Active Comparator
Arm Description
FPH Device with SensAwake On + Pressure Support A
Arm Title
FPH Device with SensAwake Off + Pressure Support A
Arm Type
Active Comparator
Arm Description
FPH Device with SensAwake Off + Pressure Support A
Arm Title
FPH Device with SensAwake On + Pressure Support B
Arm Type
Active Comparator
Arm Description
FPH Device with SensAwake On + Pressure Support B
Arm Title
FPH Device with SensAwake Off + Pressure Support B
Arm Type
Active Comparator
Arm Description
FPH Device with SensAwake Off + Pressure Support B
Arm Title
Competitor's PAP Released Device + Pressure Support A
Arm Type
Active Comparator
Arm Description
Competitor's PAP Released Device + Pressure Support A
Arm Title
Competitor's PAP Released Device + Pressure Support B
Arm Type
Active Comparator
Arm Description
Competitor's PAP Released Device + Pressure Support B
Intervention Type
Device
Intervention Name(s)
FPH Device with SensAwake On + Pressure Support A
Intervention Description
FPH Device with SensAwake On + Pressure Support A
Intervention Type
Device
Intervention Name(s)
FPH Device with SensAwake Off + Pressure Support A
Intervention Description
FPH Device with SensAwake Off + Pressure Support A
Intervention Type
Device
Intervention Name(s)
FPH Device with SensAwake On + Pressure Support B
Intervention Description
FPH Device with SensAwake On + Pressure Support B
Intervention Type
Device
Intervention Name(s)
FPH Device with SensAwake Off + Pressure Support B
Intervention Description
FPH Device with SensAwake Off + Pressure Support B
Intervention Type
Device
Intervention Name(s)
Competitor's PAP Released Device + Pressure Support A
Intervention Description
Competitor's PAP Released Device + Pressure Support A
Intervention Type
Device
Intervention Name(s)
Competitor's PAP Released Device + Pressure Support B
Intervention Description
Competitor's PAP Released Device + Pressure Support B
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Description
Through the device and independent flow logger
Time Frame
3 nights
Title
Apnea Hypopnea Index (AHI)
Description
Through the polysomnography
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Therapy Comfort
Description
Through a subjective questionnaire
Time Frame
3 nights
Title
Compliance
Description
Through the device and independent flow logger
Time Frame
3 nights
Title
Device Triggering
Description
Through the device
Time Frame
3 nights
Title
Device Triggering
Description
Through the polysomnography
Time Frame
1 night

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18 and over Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) - (Continuous Positive Airway Pressure (CPAP) or AutoCPAP). Participants can be naïve to CPAP or experienced users of CPAP. For experienced users of PAP (CPAP or AutoCPAP): Using the PAP of more than 4 hours/night for 70% during the last 30 days (justification allowed by the investigator) Exclusion Criteria: Contraindicated for PAP (CPAP or AutoCPAP) therapy Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea) Persons with obesity hypoventilation syndrome or congestive heart failure. Persons that require supplemental oxygen with their PAP (CPAP or AutoCPAP) device Persons with implanted electronic medical device (e.g cardiac pacemakers) Persons who are pregnant or think they might be pregnant.
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
0600
Country
New Zealand
Facility Name
WellSleep Centre
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

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