Toffee Full Face and Toffee Nasal Mask Evaluation in Obes... | NCT02486380

Studies
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

NCT02486380

Sponsor

Fisher and Paykel Healthcare

Status

Terminated

Last Update Posted

Jun 24, 2022Actual

Enrollment

4Actual

Phase

Not Applicable

Conditions

Obesity Hypoventilation Syndrome

Interventions

Toffee full face mask/toffee 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

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Recruitment terminated permanently due to limited resource to recruit.

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Jun 25, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 1, 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

Jun 19, 2022

Last Update Posted Date

Jun 24, 2022Actual

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 to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.

Detailed Description

Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F&P Toffee Full face (if they are existing full face users) or F&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.

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

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Full face/Nasal masks	Experimental	Toffee Full face/Toffee nasal	Device: Toffee full face mask/toffee nasal mask

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Toffee full face mask/toffee nasal mask	Device	Toffee full face mask/toffee nasal mask	Full face/Nasal masks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objective Leak data	Obtained from the participant's device and polysomnography (PSG)	1 night

Secondary Outcomes

Measure	Description	Time Frame
Subjective measurement of Leak	Questionnaire	1 night
Comfort	Questionnaire	1 night

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged 18+
Diagnosed with OHS by a practicing physician
Existing full face mask user or a nasal mask user
Prescribed PAP therapy (Bi-Level or CPAP)

Exclusion Criteria:

Inability to give informed consent
Pregnant or think they may be pregnant
Anatomical or physiological conditions making PAP therapy inappropriate
Patients requiring supplemental oxygen with their PAP device
Patients who are in a coma or decreased level of consciousness
Existing Toffee full face and Toffee nasal mask users
No arterial PCO2 value from their medical records

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, BSc	Fisher & Paykel Healthcare	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D010845	Obesity Hypoventilation Syndrome

Ancestor Terms

ID	Term
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided