Skip to main content
OpenTrials
Completed

NCT Number: NCT01824979

Pilairo Lab Market Research

The purpose of the study is to observe the Pilairo mask in a lab setting.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peninsula Sleep Center Inc

Burlingame, California, 94010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP mask ( Pilairo)

Device

Other CPAP mask

Procedure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 5, 2013
Registry last updated
Mar 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.