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OpenTrials
Completed

NCT Number: NCT02323035

Investigative Headgear With 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 2-4 weeks.

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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

Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

Who can participate

Healthy volunteers accepted: Yes

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 Bilevel therapy for OSA
  • Existing CPAP mask users

Exclusion criteria

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

Treatment and study plan

Headgear

Device

Investigative Headgear with CPAP Mask.

Primary outcomes

  1. Participants perception of the headgear on mask performance

    Time frame: 2-4 weeks

    Assess if the headgear with mask changes the perception of the performance of the mask.

Secondary outcomes

  1. Number of participants that choose this Headgear over their usual.

    Time frame: 2-4 weeks

    Assess the acceptability of the headgear with mask.

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 23, 2014
Registry last updated
Apr 18, 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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