The Evaluation of an Interface for the Treatment of Obstr... | NCT03725839

Studies
The Evaluation of an Interface for the Treatment of Obstructive Sleep Apnea (OSA)

NCT03725839

Sponsor

Fisher and Paykel Healthcare

Status

Completed

Last Update Posted

Feb 28, 2020Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Sleep Disordered Breathing
Obstructive Sleep Apnea

Interventions

F&P Interface

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

Feb 2020

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

Nov 5, 2018Actual

Primary Completion Date

Nov 30, 2019Actual

Completion Date

Nov 30, 2019Actual

First Submitted Date

Oct 28, 2018

First Submission Date that Met QC Criteria

Oct 29, 2018

First Posted Date

Oct 31, 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

Feb 26, 2020

Last Update Posted Date

Feb 28, 2020Actual

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 interface.

Detailed Description

A minimum of 40 OSA participants who currently use CPAP will be recruited for the trial. Participant will be in the trial for three weeks- first week will be a collection of Positive Airway Pressure baseline data on participant's usual interface. The participant will then use the trial interface in-home for 2 weeks. There is also an option of a six month extension if the participant wish to continue on the trial interface.

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm	Experimental	F&P Interface will be used by OSA participants in-home for 2 weeks.	Device: F&P Interface

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Trial Mask usability	Questionnaire on ease-of-use (very easy to very difficult) Subjective	14 ± 4 days in home
Trial mask Performance	Questionnaire on performance (very good to very poor)- Subjective	14 ± 4 days in home

Secondary Outcomes

Measure	Description	Time Frame
Trial mask Reliability	Questionnaire on reliability - Subjective	5 months and 2 weeks in home
Trial mask performance measured in L/min	Objective leak data from PAP device

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult (18+ years of age)
Able to give written consent
AHI ≥ 5 on diagnostic night
Either prescribed APAP, CPAP or Bi-level PAP for OSA

Exclusion Criteria:

Inability to give written consent
Anatomical or physiological conditions making PAP therapy inappropriate
Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
Current diagnosis of respiratory disease or 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
Bhavi Ogra	Clinical Manager	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hawkes Bay Fallen Soldiers' Memorial Hospital		Hastings	Hawkes Bay	4120	New Zealand
Fisher & Paykel Healthcare

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