CPAP Device In-lab Assessment NZ

Obstructive Sleep Apnea Clinical Trial

Official title:

CPAP Device In-lab Assessment NZ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02948010
• Other study ID #: CIA187
• Status: Completed
• Phase: N/A
• First received: October 26, 2016
• Last updated: June 26, 2017
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Auto CPAP + comfort feature A
Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device
• Auto CPAP with comfort feature B
Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
• Auto CPAP with no comfort feature
Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
• Auto CPAP with comfort feature A+B
Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
• CPAP with comfort feature A
CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
• CPAP with comfort feature B
CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
• CPAP with no comfort feature
CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
• CPAP with comfort feature A + B
CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
• CPAP at Sub therapeutic level
CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI) (i.e. number of events/hour).	Obtained from device and PSG data	4 months
Primary	Log of safety-related events, measured as number of safety-related faults	Obtained from device	4 months
Primary	Machine reported faults, measured as number of machine faults	Obtained from device	4 months
Secondary	Participant perception of the device, as determined by the questionnaire responses	Obtained through user questionnaire	4 months