CPAP In-home Assessment NZ

August 1, 2018 updated by: Fisher and Paykel Healthcare

Phase 1:The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 6 months.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Phase 1:Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

Study Type

Interventional

Enrollment (Actual)

30

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

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 Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
  • Be fluent in spoken and written English

Exclusion Criteria:

  • Contraindicated for Positive Airway Pressure (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 Positive Airway Pressure (CPAP or AutoCPAP) device.
  • Persons with implanted electronic medical devices (e.g cardiac pacemakers)
  • Persons who are pregnant or think they may 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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Investigational CPAP device
Fisher & Paykel Healthcare CPAP Device
Device: Fisher & Paykel Healthcare CPAP Device
Fisher & Paykel Healthcare CPAP Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI), measured as number of events/hour hour.
Time Frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
6 months
Log of safety-related events, measured as number of safety-related faults
Time Frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
6 months
Machine reported faults, measured as number of machine faults
Time Frame: 6 months
Obtained from the device - Phase 1 and Phase 2 of the trial
6 months
Participant reported faults, measured as number of participant complaints
Time Frame: 6 months
Obtained from the follow up visits - Phase 1 and Phase 2 of the trial
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perception of the device, measured through questionnaire
Time Frame: 6 months
Impression of the device during the follow up visits - Phase 1 only
6 months

Collaborators and Investigators

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

Sponsor

Fisher and Paykel Healthcare

Investigators

  • Principal Investigator: Irene Cheung, MSc/RPSGT, Fisher & 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

July 1, 2016

Primary Completion (ACTUAL)

June 16, 2017

Study Completion (ACTUAL)

June 16, 2017

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 3, 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

  • CIA174

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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