CPAP Device In-lab Assessment NZ

Fisher & Paykel Healthcare

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP with no comfort feature; Device: CPAP with comfort feature B; Device: CPAP with comfort feature A; Device: Auto CPAP with comfort feature A+B; Device: CPAP with comfort feature A + B; Device: Auto CPAP with comfort feature B; Device: Auto CPAP + comfort feature A; Device: CPAP at Sub therapeutic level; Device: Auto CPAP with no comfort feature

Study type: Interventional

Funder types: Industry

Identifiers

NCT02948010

CIA187

Details and patient eligibility

About

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

Full description

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.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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104 participants in 9 patient groups

Auto CPAP + comfort feature A

Active Comparator group

Description:

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

Treatment:

Device: Auto CPAP + comfort feature A

Auto CPAP with comfort feature B

Active Comparator group

Description:

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

Treatment:

Device: Auto CPAP with comfort feature B

Auto CPAP with no comfort feature

Active Comparator group

Description:

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

Treatment:

Device: Auto CPAP with no comfort feature

Auto CPAP with comfort feature A+B

Active Comparator group

Description:

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

Treatment:

Device: Auto CPAP with comfort feature A+B

CPAP with comfort feature A

Active Comparator group

Description:

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

Treatment:

Device: CPAP with comfort feature A

CPAP with comfort feature B

Active Comparator group

Description:

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

Treatment:

Device: CPAP with comfort feature B

CPAP with no comfort feature

Active Comparator group

Description:

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

Treatment:

Device: CPAP with no comfort feature

CPAP with comfort feature A + B

Active Comparator group

Description:

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

Treatment:

Device: CPAP with comfort feature A + B

CPAP at Sub therapeutic level

Active Comparator group

Description:

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

Treatment:

Device: CPAP at Sub therapeutic level