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Completed

NCT Number: NCT02948010

CPAP Device In-lab Assessment NZ

The purpose of this trial is to assess device performance against participants in an overnight study to ensure the product meets user and clinical requirements

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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

Existing Adult Continuous Positive Airway Pressure (CPAP) therapy users will be recruited for an overnight polysomnography (PSG) sleep study. The participants will use the investigational CPAP device and be connected to a PSG during their session. The device performance during the session will be assessed. Outcomes of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires and PSG data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years or older
  • Diagnosed with OSA by a practicing physician and prescribed PAP therapy (fixed or auto CPAP)
  • Fluent in spoken and written English.

Exclusion criteria

  • Be contraindicated for PAP (fixed or auto CPAP) therapy.
  • Have another significant sleep disorder(s) (e.g. periodic leg movements or insomnia).
  • Have obesity hypoventilation syndrome or congestive heart failure.
  • Require supplemental oxygen with your PAP (fixed or auto CPAP) device.
  • Have any implanted electronic medical devices (e.g. cardiac pacemakers).
  • Be pregnant or think they might be pregnant.

Treatment and study plan

Auto CPAP + comfort feature A

Device

Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device

Auto CPAP with comfort feature B

Device

Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device

Auto CPAP with no comfort feature

Device

Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device

Auto CPAP with comfort feature A+B

Device

Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device

CPAP with comfort feature A

Device

CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device

CPAP with comfort feature B

Device

CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device

CPAP with no comfort feature

Device

CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device

CPAP with comfort feature A + B

Device

CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device

CPAP at Sub therapeutic level

Device

CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device

Primary outcomes

  1. Apnea Hypopnea Index (AHI) (i.e. number of events/hour).

    Time frame: 4 months

    Obtained from device and PSG data

  2. Log of safety-related events, measured as number of safety-related faults

    Time frame: 4 months

    Obtained from device

  3. Machine reported faults, measured as number of machine faults

    Time frame: 4 months

    Obtained from device

Secondary outcomes

  1. Participant perception of the device, as determined by the questionnaire responses

    Time frame: 4 months

    Obtained through user questionnaire

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 28, 2016
Registry last updated
Jun 27, 2017

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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