Pilairo Lab Market Research

February 8, 2018 updated by: Fisher and Paykel Healthcare
The purpose of the study is to observe the Pilairo mask in a lab setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of the study is to observe the Pilairo mask in a lab setting, compared to other commercially available masks for continuous positive airwary pressure (CPAP) therapy.

Study Type

Interventional

Enrollment (Actual)

100

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
    • California
      • Burlingame, California, United States, 94010
        • Peninsula Sleep Center Inc

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:

  • Apnea Hypopnea Indea >15 from diagnostic study
  • Minimum 18 years of age

Exclusion Criteria:

  • Inability ot give informed consent
  • History of intolerance to CPAP
  • Anatomical or physiological conditions making CPAP therapy inappropriate

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pilairo mask
Pilairo nasal pillows mask during CPAP titration
Device: CPAP mask ( Pilairo)
Active Comparator: Other CPAP mask
Other CPAP mask during CPAP titration
Procedure: Other CPAP mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technician Experience With Mask
Time Frame: One night
Measured from a single item, sleep technicians indicated their experience using the Pilairo or Other CPAP mask during the CPAP titration. Response options ranged on a scale from 0 to 10 with 0 indicating an extremely poor experience and 10 indicating and extremely pleasant experience.
One night

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Mask Interventions During the Night
Time Frame: One night
Sleep technicians reported the number of times they had to intervene with the mask to get a good seal or improve comfort.
One 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, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 4, 2013

First Posted (Estimate)

April 5, 2013

Study Record Updates

Last Update Posted (Actual)

March 9, 2018

Last Update Submitted That Met QC Criteria

February 8, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIA76

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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