CPAP In-home Assessment Australia | NCT02809794

Studies
CPAP In-home Assessment Australia

NCT02809794

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Jun 27, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Fisher & Paykel Healthcare CPAP Device

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Jun 19, 2016

First Submission Date that Met QC Criteria

Jun 19, 2016

First Posted Date

Jun 22, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2017

Last Update Posted Date

Jun 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Investigational CPAP device	Experimental	Fisher & Paykel Healthcare CPAP Device	Device: Fisher & Paykel Healthcare CPAP Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fisher & Paykel Healthcare CPAP Device	Device	Fisher & Paykel Healthcare CPAP Device	Investigational CPAP device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Perception of the device, measured through questionnaire	Impression of the device during the follow up visits	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18 and over.
Diagnosed with OSA by a practicing physician and prescribed Positive Airway Pressure (PAP) therapy.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Sleep Matters		Bulleen	Victoria	3105	Australia
Sleep & Snore Solutions

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided