The Evaluation of a Novel Nasal Mask for the Treatment of... | NCT03413098

Studies
The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

NCT03413098

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Mar 22, 2018Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Nasal CPAP 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

Jan 2018

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

Feb 12, 2018Actual

Primary Completion Date

Mar 9, 2018Actual

Completion Date

Mar 9, 2018Actual

First Submitted Date

Jan 22, 2018

First Submission Date that Met QC Criteria

Jan 22, 2018

First Posted Date

Jan 29, 2018Actual

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

Mar 20, 2018

Last Update Posted Date

Mar 22, 2018Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.

Detailed Description

Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial nasal mask for use in-home.

The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

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

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trial nasal Continuous Positive Airway Pressure (CPAP) mask	Experimental	Trial nasal CPAP mask	Device: Nasal CPAP mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasal CPAP mask	Device	Investigative Nasal Mask to be used for OSA therapy	Trial nasal Continuous Positive Airway Pressure (CPAP) mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ease of use	Subjective Questionnaire	2 weeks
Acceptability	Subjective Questionnaire	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Objective leak data	Data obtained from participant's device - Objective	2 weeks

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 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	Sponsor Employee	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hastings Memorial Hospital		Hastings			New Zealand
WellSleep

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