CPAP In-home Assessment Australia
1 other identifier
interventional
50
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2016
Shorter than P25 for not_applicable
3 active sites
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 19, 2016
CompletedFirst Posted
Study publicly available on registry
June 22, 2016
CompletedStudy Start
First participant enrolled
July 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJune 27, 2017
June 1, 2017
8 months
June 19, 2016
June 26, 2017
Conditions
Outcome Measures
Primary Outcomes (4)
Apnea Hypopnea Index (AHI), measured as number of events/hour
Obtained from the device
6 months
Log of safety-related events, measured as number of safety-related faults
Obtained from the device
6 months
Machine reported faults, measured as number of machine faults
Obtained from the device
6 months
Participant reported faults, measured as number of participant complaints
Obtained from the follow up visits
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 OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.
You may not qualify if:
- Persons contraindicated for Continuous Positive Airway Pressure (CPAP) 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 CPAP device.
- Persons with implanted electronic medical devices (e.g. cardiac pacemakers).
- Persons who are pregnant or think they might be pregnant.
- Persons whose primary language is other than English.
- Persons in existing dependent or unequal relationships with any member of the research team, the researcher(s) and/or the person undertaking the recruitment/consent process.
- Persons highly dependent on medical care.
- People with cognitive impairment, an intellectual disability or a mental illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Sleep Matters
Bulleen, Victoria, 3105, Australia
Sleep & Snore Solutions
Bunbury, Western Australia, 6230, Australia
St John of God Midland Public Hospital
Midland, Western Australia, 6056, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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 19, 2016
First Posted
June 22, 2016
Study Start
July 1, 2016
Primary Completion
March 1, 2017
Study Completion
March 1, 2017
Last Updated
June 27, 2017
Record last verified: 2017-06