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

Fisher & Paykel Healthcare

Status: Terminated

Conditions: Obesity Hypoventilation Syndrome

Treatments: Device: Toffee full face mask/toffee nasal mask

Study type: Interventional

Funder types: Industry

Identifiers

NCT02486380

CIA-162

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

Full face/Nasal masks

Experimental group

Description:

Toffee Full face/Toffee nasal

Treatment:

Device: Toffee full face mask/toffee nasal mask