The Evaluation of a Mask Seal/Mask for the Treatment of O... | NCT03092921

Studies
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

NCT03092921

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Aug 8, 2017Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Sleep Disordered Breathing
Obstructive Sleep Apnea

Interventions

F&P Mask Seal
F&P Mask

Countries

New Zealand

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

Aug 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

Mar 27, 2017Actual

Primary Completion Date

Aug 3, 2017Actual

Completion Date

Aug 3, 2017Actual

First Submitted Date

Mar 22, 2017

First Submission Date that Met QC Criteria

Mar 22, 2017

First Posted Date

Mar 28, 2017Actual

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

Aug 6, 2017

Last Update Posted Date

Aug 8, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 as well as the patients overall acceptance of the seal/mask.

Detailed Description

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

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

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
F&P Mask Seal	Experimental	Participants to use trial seal in-home for 1 week	Device: F&P Mask Seal
F&P Mask	Experimental	Participants to use trial mask in-home for 2 weeks	Device: F&P Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
F&P Mask Seal	Device	Investigative Mask Seal to be used for OSA therapy	F&P Mask Seal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ease of use	Subjective questionnaire	1 week in home
Acceptability	Subjective questionnaire	1 week in home
Ease of use	Subjective questionnaire	2 weeks in home
Acceptability	Subjective questionnaire	2 weeks in home

Secondary Outcomes

Measure	Description	Time Frame
Objective leak data	Obtained from participants' device	1 week in home

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (18+ years of age)
Able to give consent
Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
Prescribed PAP for OSA
Existing oro-nasal mask user

Exclusion Criteria:

Inability to give consent
Patients who are in a coma or a decreased level of consciousness
Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
Commercial drivers who are investigated by New Zealand Transport Agency
Current diagnosis of carbon dioxide (CO2) retention
Pregnant or may think they are 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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Gunson	Employee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fisher & Paykel Healthcare		Auckland		2013	New Zealand

IPD Sharing Statement Module

Plan to Share IPD

Description

For product development purposes only. Data will be deidentified.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided