Evaluation of a Full Face Mask for the Treatment of Obstr... | NCT02540603

Studies
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ

NCT02540603

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Apr 20, 2017Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

F&P Jupiter Full Face Mask

Countries

Not provided

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

Apr 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

Sep 2015

Primary Completion Date

Oct 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Aug 28, 2015

First Submission Date that Met QC Criteria

Sep 3, 2015

First Posted Date

Sep 4, 2015Estimated

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

Apr 18, 2017

Last Update Posted Date

Apr 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.

Detailed Description

A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial. Participants will be on the trial for three weeks, using the prototypes at home for two weeks. PAP baseline data on the participant's prescribed treatment pressure with their usual mask and will be collected for one week prior to mask fitting with the full face trial mask.

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

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full Face Mask	Experimental	F&P Jupiter Full Face Mask with Headgear	Device: F&P Jupiter Full Face Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
F&P Jupiter Full Face Mask	Device	Investigative F&P Jupiter full face mask to be used for OSA therapy	Full Face Mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with average system leak >60L/min	Average system leak will be recorded through downloading of the data from the PAP device in L/min.	Two weeks in-home use

Secondary Outcomes

Measure	Description	Time Frame
Insights into mask fitting and removal.	Observations of the action of fitting the mask and removing the mask will be noted.	Two weeks use
Number of participants that found the mask comfortable.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18+ years of age
Diagnosed with OSA by a practicing physician
Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
Existing full face users

Exclusion Criteria:

Inability to give informed consent
Patients who are in a coma or decreased level of consciousness
Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
Current diagnosis of CO2 retention
Pregnant or think they may be pregnant

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Data will be shared to any other parties.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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