Back to resultsToffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
Primary Purpose
Obesity Hypoventilation Syndrome
Status
Terminated
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Toffee full face mask/toffee nasal mask
Sponsored by
About this trial
This is an interventional treatment trial for Obesity Hypoventilation Syndrome
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
Sites / Locations
- Fisher & Paykel Healthcare
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Full face/Nasal masks
Arm Description
Toffee Full face/Toffee nasal
Outcomes
Primary Outcome Measures
Objective Leak data
Obtained from the participant's device and polysomnography (PSG)
Secondary Outcome Measures
Subjective measurement of Leak
Questionnaire
Comfort
Questionnaire
Ease of use
Questionnaire
Sleep efficiency
Obtained through the PSG
Wake after Sleep Onset (WASO)
Obtained through the PSG
Arousal Index (AI)
Obtained through the PSG
Full Information
NCT ID
NCT02486380
First Posted
June 25, 2015
Last Updated
June 19, 2022
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02486380
Brief Title
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
Official Title
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment terminated permanently due to limited resource to recruit.
Study Start Date
July 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity Hypoventilation Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full face/Nasal masks
Arm Type
Experimental
Arm Description
Toffee Full face/Toffee nasal
Intervention Type
Device
Intervention Name(s)
Toffee full face mask/toffee nasal mask
Intervention Description
Toffee full face mask/toffee nasal mask
Primary Outcome Measure Information:
Title
Objective Leak data
Description
Obtained from the participant's device and polysomnography (PSG)
Time Frame
1 night
Secondary Outcome Measure Information:
Title
Subjective measurement of Leak
Description
Questionnaire
Time Frame
1 night
Title
Comfort
Description
Questionnaire
Time Frame
1 night
Title
Ease of use
Description
Questionnaire
Time Frame
1 night
Title
Sleep efficiency
Description
Obtained through the PSG
Time Frame
1 night
Title
Wake after Sleep Onset (WASO)
Description
Obtained through the PSG
Time Frame
1 night
Title
Arousal Index (AI)
Description
Obtained through the PSG
Time Frame
1 night
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bhavi Ogra, BSc
Organizational Affiliation
Fisher & Paykel Healthcare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fisher & Paykel Healthcare
City
Auckland
ZIP/Postal Code
2013
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
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