CPAP Device In-lab Assessment NZ

June 26, 2017 updated by: Fisher and Paykel Healthcare
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

104

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, 2013
        • Fisher & Paykel Healthcare

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:

  • 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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Auto CPAP + comfort feature A
Auto CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
Device: Auto CPAP + comfort feature A
Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device
Active Comparator: Auto CPAP with comfort feature B
Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Device: Auto CPAP with comfort feature B
Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Active Comparator: Auto CPAP with no comfort feature
Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Device: Auto CPAP with no comfort feature
Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Active Comparator: Auto CPAP with comfort feature A+B
Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
Device: Auto CPAP with comfort feature A+B
Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
Active Comparator: CPAP with comfort feature A
CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
Device: CPAP with comfort feature A
CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
Active Comparator: CPAP with comfort feature B
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Device: CPAP with comfort feature B
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
Active Comparator: CPAP with no comfort feature
CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Device: CPAP with no comfort feature
CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
Active Comparator: CPAP with comfort feature A + B
CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
Device: CPAP with comfort feature A + B
CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
Active Comparator: CPAP at Sub therapeutic level
CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device
Device: CPAP at Sub therapeutic level
CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI) (i.e. number of events/hour).
Time Frame: 4 months
Obtained from device and PSG data
4 months
Log of safety-related events, measured as number of safety-related faults
Time Frame: 4 months
Obtained from device
4 months
Machine reported faults, measured as number of machine faults
Time Frame: 4 months
Obtained from device
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant perception of the device, as determined by the questionnaire responses
Time Frame: 4 months
Obtained through user questionnaire
4 months

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

November 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 26, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

June 27, 2017

Last Update Submitted That Met QC Criteria

June 26, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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