CPAP In-home Assessment USA

February 12, 2019 updated by: Fisher and Paykel Healthcare
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

139

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

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Alabama Sleep Clinic
    • Florida
      • Kissimmee, Florida, United States, 34741
        • Pulmonary Disease Specialists - Central Florida Sleep Centre
    • Missouri
      • Saint Louis, Missouri, United States, 63143
        • Clayton Sleep Institute
    • Ohio
      • Dublin, Ohio, United States, 43017
        • Ohio Sleep Medicine and Neurosciences Institute

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

22 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 22 and over
  • Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
  • For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion Criteria:

  • Contraindicated for PAP (CPAP or AutoCPAP) therapy
  • Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
  • Has obesity hypoventilation syndrome or congestive heart failure
  • Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
  • Has implanted electronic medical devices (e.g cardiac pacemakers)
  • Pregnant or think they may be pregnant
  • Not fluent in spoken and written English.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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
Time Frame
Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.
Time Frame: 6 months
6 months
Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults
Time Frame: 6 months
6 months
Machine Reported Faults, Measured as Number of Patients With Machine Faults
Time Frame: 6 months
6 months
Participant Reported Faults, Measured as Number of Participant Complaints
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device
Time Frame: 6 months
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: Matt Uhles, Clayton Sleep Institute

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)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

June 19, 2016

First Submitted That Met QC Criteria

June 19, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 5, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA176

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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