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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity Hypoventilation Syndrome
• Intervention / Treatment: Device: Toffee full face mask/toffee nasal mask

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand, 2013
    • Fisher & Paykel Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full face/Nasal masks; Toffee Full face/Toffee nasal	Device: Toffee full face mask/toffee nasal mask; Toffee full face mask/toffee nasal mask

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Bhavi Ogra, BSc, Fisher & Paykel Healthcare

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 25, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 1, 2015

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Insufficiency; Sleep Apnea, Obstructive; Syndrome; Obesity; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: CIA-162