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

August 1, 2018 updated by: Fisher and Paykel Healthcare
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand, 0600
        • Fisher & Paykel Healthcare
      • Wellington, New Zealand, 6035
        • WellSleep Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: FPH Device with SensAwake On + Pressure Support A
Device: FPH Device with SensAwake On + Pressure Support A
FPH Device with SensAwake On + Pressure Support A
Active Comparator: FPH Device with SensAwake Off + Pressure Support A
Device: FPH Device with SensAwake Off + Pressure Support A
FPH Device with SensAwake Off + Pressure Support A
Active Comparator: FPH Device with SensAwake On + Pressure Support B
Device: FPH Device with SensAwake On + Pressure Support B
FPH Device with SensAwake On + Pressure Support B
Active Comparator: FPH Device with SensAwake Off + Pressure Support B
Device: FPH Device with SensAwake Off + Pressure Support B
FPH Device with SensAwake Off + Pressure Support B
Active Comparator: Competitor's PAP Released Device + Pressure Support A
Device: Competitor's PAP Released Device + Pressure Support A
Competitor's PAP Released Device + Pressure Support A
Active Comparator: Competitor's PAP Released Device + Pressure Support B
Device: Competitor's PAP Released Device + Pressure Support B
Competitor's PAP Released Device + Pressure Support B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI)
Time Frame: 3 nights
Through the device and independent flow logger
3 nights
Apnea Hypopnea Index (AHI)
Time Frame: 1 night
Through the polysomnography
1 night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy Comfort
Time Frame: 3 nights
Through a subjective questionnaire
3 nights
Compliance
Time Frame: 3 nights
Through the device and independent flow logger
3 nights
Device Triggering
Time Frame: 3 nights
Through the device
3 nights
Device Triggering
Time Frame: 1 night
Through the polysomnography
1 night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fisher and Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

November 17, 2016

First Submitted That Met QC Criteria

November 18, 2016

First Posted (Estimate)

November 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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