Investigative Headgear With CPAP Mask | NCT02323035

Studies
Investigative Headgear With CPAP Mask

NCT02323035

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Apr 18, 2019Actual

Enrollment

23Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

Headgear

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

Apr 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

Dec 2014

Primary Completion Date

Nov 2016Actual

Completion Date

Nov 2016Actual

First Submitted Date

Dec 15, 2014

First Submission Date that Met QC Criteria

Dec 17, 2014

First Posted Date

Dec 23, 2014Estimated

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 16, 2019

Last Update Posted Date

Apr 18, 2019Actual

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

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the Headgear with a CPAP Mask for a duration of 2-4 weeks.

Detailed Description

Up to 300 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level PAP for the treatment of their OSA. These include current CPAP mask users.

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

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Headgear	Experimental	Investigative Headgear with CPAP Mask.	Device: Headgear

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Headgear	Device	Investigative Headgear with CPAP Mask.	Headgear

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants perception of the headgear on mask performance	Assess if the headgear with mask changes the perception of the performance of the mask.	2-4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Number of participants that choose this Headgear over their usual.	Assess the acceptability of the headgear with mask.	2-4 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AHI≥5 from the diagnostic night
≥18 years of age
Prescribed CPAP or Bilevel therapy for OSA
Existing CPAP mask users

Exclusion Criteria:

Inability to give informed consent
Patient intolerant to PAP
Anatomical or physiological conditions making PAP therapy inappropriate
History of respiratory disease or CO2 retention.
Pregnant or think they may be pregnant
Investigated by Land Transport Safety Authority

Accepts Healthy Volunteers

Yes

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
Bhavi Ogra, BSc	Clinical Research Scientist	Principal Investigator

Locations

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

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

Intervention Browse Module

MeSH Terms

ID	Term
D005115	Extraoral Traction Appliances

Ancestor Terms

ID	Term
D009968	Orthodontic Appliances, Removable
D009967	Orthodontic Appliances
D009970	Orthodontics
D003813	Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided