CPAP In-home Assessment NZ

Obstructive Sleep Apnea Clinical Trial

Official title:

CPAP In-home Assessment NZ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804919
• Other study ID #: CIA174
• Status: Completed
• Phase: N/A
• Start date: July 2016
• Est. completion date: June 16, 2017

Study information

• Verified date: August 2018
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 1: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.

Phase 2: To evaluate the CPAP device with communication functionality with data upload.

Description:

Phase 1: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.

Phase 2: 10 participants from Phase 1 will be recruited to use the device for up to 6 month in-home. Participants will attend 3 study visits at day 0, 7 30. The trial may be extended to 60 days if longer term data is required.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 16, 2017
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 and over

• Diagnosed with Obstructive Sleep Apnea (OSA) and prescribed Positive Airway Pressure (either Continuous positive airway pressure (CPAP) or AutoCPAP)

• Be fluent in spoken and written English

Exclusion Criteria:

• Contraindicated for Positive Airway Pressure (CPAP or AutoCPAP) therapy

• Persons with other significant sleep disorder(s) (e.g periodic leg movements, insomnia, central sleep apnea)

• Persons with obesity hypoventilation syndrome or congestive heart failure

• Persons that require supplemental oxygen with their Positive Airway Pressure (CPAP or AutoCPAP) device.

• Persons with implanted electronic medical devices (e.g cardiac pacemakers)

• Persons who are pregnant or think they may be pregnant.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Fisher & Paykel Healthcare CPAP Device
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), measured as number of events/hour hour.	Obtained from the device - Phase 1 and Phase 2 of the trial	6 months
Primary	Log of safety-related events, measured as number of safety-related faults	Obtained from the device - Phase 1 and Phase 2 of the trial	6 months
Primary	Machine reported faults, measured as number of machine faults	Obtained from the device - Phase 1 and Phase 2 of the trial	6 months
Primary	Participant reported faults, measured as number of participant complaints	Obtained from the follow up visits - Phase 1 and Phase 2 of the trial	6 months
Secondary	Perception of the device, measured through questionnaire	Impression of the device during the follow up visits - Phase 1 only	6 months