Evaluation of a Nasal Mask for the Treatment of Obstructi... | NCT02541214

Studies
Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand

NCT02541214

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Aug 2, 2019Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Trial Nasal 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

Jul 2019

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

Nov 2015Actual

First Submitted Date

Sep 1, 2015

First Submission Date that Met QC Criteria

Sep 2, 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

Jul 31, 2019

Last Update Posted Date

Aug 2, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

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

Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.

Detailed Description

Not provided

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

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial Nasal Mask	Experimental	The participant will use the Saturn nasal mask for 2 weeks in home	Device: Trial Nasal Mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Trial Nasal Mask	Device		Trial Nasal Mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire		2 weeks in home

Secondary Outcomes

Measure	Description	Time Frame
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.	the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"	2 weeks in home

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18+
Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
Existing nasal or nasal pillows user
Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion Criteria:

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

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Waikato District Health Board		Hamilton		3240	New Zealand
Hawke's Bay District Health Board

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