CPAP In-home Assessment NZ
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 16, 2017
CompletedAugust 3, 2018
August 1, 2018
12 months
June 15, 2016
August 1, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
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
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
Machine reported faults, measured as number of machine faults
Obtained from the device - Phase 1 and Phase 2 of the trial
6 months
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 Outcomes (1)
Perception of the device, measured through questionnaire
6 months
Study Arms (1)
Investigational CPAP device
EXPERIMENTALFisher \& Paykel Healthcare CPAP Device
Interventions
Fisher \& Paykel Healthcare CPAP Device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fisher & Paykel Healthcare
Auckland, 0600, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irene Cheung, MSc/RPSGT
Fisher & Paykel Healthcare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2016
First Posted
June 17, 2016
Study Start
July 1, 2016
Primary Completion
June 16, 2017
Study Completion
June 16, 2017
Last Updated
August 3, 2018
Record last verified: 2018-08