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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02486380

Enrollment

Registered

2015-07-01

Start date

2015-07-31

Completion date

2017-03-31

Last updated

2022-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity Hypoventilation Syndrome

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.

Interventions

DEVICEToffee full face mask/toffee nasal mask

Toffee full face mask/toffee nasal mask

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Comfort	1 night	Questionnaire
Ease of use	1 night	Questionnaire
Subjective measurement of Leak	1 night	Questionnaire
Wake after Sleep Onset (WASO)	1 night	Obtained through the PSG
Arousal Index (AI)	1 night	Obtained through the PSG
Sleep efficiency	1 night	Obtained through the PSG

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026