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Completed

NCT Number: NCT02809859

CPAP In-home Assessment USA

The study is to evaluate the product reliability, therapy effectiveness and user feedback of a Continuous Positive Airway Pressure (CPAP) device in-home for up to 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

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alabama Sleep Clinic, Huntsville, Alabama, United States

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About this study

Existing and Naïve CPAP users will be recruited into a 6 month in-home study Participants will attend 5 study visits at day 0, 7, 30, 60 and 180. Outcome of the clinical investigation include downloadable device data reports, device error reports and participants perception questionnaires.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 22 and over
  • Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)
  • For experienced users of PAP (CPAP or AutoCPAP) - you must be using PAP of more than 4 hours/night for 70% during the last 30 days.

Exclusion criteria

  • Contraindicated for PAP (CPAP or AutoCPAP) therapy
  • Has other significant sleep disorders (e.g periodic leg movements, insomnia, central sleep apnea)
  • Has obesity hypoventilation syndrome or congestive heart failure
  • Requires supplemental oxygen with their PAP (CPAP or AutoCPAP) device
  • Has implanted electronic medical devices (e.g cardiac pacemakers)
  • Pregnant or think they may be pregnant
  • Not fluent in spoken and written English.

Treatment and study plan

Fisher & Paykel Healthcare CPAP Device

Device

Fisher & Paykel Healthcare CPAP Device

Primary outcomes

  1. Apnea Hypopnea Index (AHI), Measured as Number of Events/Hour.

    Time frame: 6 months

  2. Log of Safety Related Events, Measured as Number of Participants That Experienced Unacceptable Safety Related Faults

    Time frame: 6 months

  3. Machine Reported Faults, Measured as Number of Patients With Machine Faults

    Time frame: 6 months

  4. Participant Reported Faults, Measured as Number of Participant Complaints

    Time frame: 6 months

Secondary outcomes

  1. How Many Participants Slept Acceptably, Well or Very Well Throughout the Night on the CPAP Device

    Time frame: 6 months

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
Jun 22, 2016
Registry last updated
Mar 5, 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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