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OpenTrials
Completed

NCT Number: NCT02942446

Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

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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

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

About this study

20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • AHI≥5 from the diagnostic night
  • ≥18 years of age
  • Prescribed CPAP or Bi-level therapy for OSA
  • Existing F&P Pilairo Q, Eson, Simplus mask users

Exclusion criteria

  • Inability to give informed consent
  • Patient intolerant to CPAP
  • Anatomical or physiological conditions making CPAP therapy inappropriate
  • History of respiratory disease or carbon dioxide (CO2) retention
  • Pregnant or think they may be pregnant
  • Investigated by Land Transport Safety Authority

Treatment and study plan

Investigative Headgear with CPAP mask

Device

Investigative Headgear with CPAP mask

Primary outcomes

  1. Reliability of the headgear using a Questionnaire

    Time frame: Monthly over a period of 6 months

    Assessment of headgear properties on a monthly basis via custom questionnaire via phone call

  2. Durability of the headgear by testing

    Time frame: Monthly over a period of 6 months

    Assessment of headgear properties on a monthly basis, and changes to the headgear

Secondary outcomes

  1. Performance in regards to leak of the headgear

    Time frame: Monthly over a period of 6 months

    Objective Leak Data (L/min) from the device download

  2. Performance in regards to comfort of the headgear

    Time frame: Monthly over a period of 6 months

    Custom Questionnaire

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

Investigative Headgear With Nasal Pillows CPAP Mask

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 24, 2016
Registry last updated
Mar 21, 2019

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.

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