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

Not Applicable

Terminated

• Conditions: Obesity Hypoventilation Syndrome
• Interventions: Device: Toffee full face mask/toffee nasal mask

• Registration Number: NCT02486380
• Lead Sponsor: Fisher and Paykel Healthcare

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.

Study Timeline

• Study First Submitted: 2015-06-25
• Study First Submitted QC: 2015-06-30
• Study Start: 2015-07
• Study First Posted: 2015-07-01
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-19
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full face/Nasal masks	Toffee full face mask/toffee nasal mask	Toffee Full face/Toffee nasal

Primary Outcome Measures

Name	Time	Method
Objective Leak data	1 night	Obtained from the participant's device and polysomnography (PSG)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fisher & Paykel Healthcare; 🇳🇿 Auckland, New Zealand