Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
1 other identifier
interventional
39
1 country
2
Brief Summary
Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask. This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy. Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedAugust 2, 2019
July 1, 2019
1 month
September 1, 2015
July 31, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire
2 weeks in home
Secondary Outcomes (4)
Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.
2 weeks in home
Objective leak data through the Positive Airway Pressure therapy device
2 weeks in home
Treatment efficacy through the Positive Airway Pressure therapy device
2 weeks in home
Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.
2 weeks in home
Study Arms (1)
Trial Nasal Mask
EXPERIMENTALThe participant will use the Saturn nasal mask for 2 weeks in home
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18+
- Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
- Existing nasal or nasal pillows user
- Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))
You may not qualify if:
- Inability to give informed consent
- Pregnant or think they may be pregnant
- Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
- Patients who are in a coma or decreased level of consciousness
- Current diagnosis of CO2 retention
- Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Waikato District Health Board
Hamilton, 3240, New Zealand
Hawke's Bay District Health Board
Hastings, 9014, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 4, 2015
Study Start
September 1, 2015
Primary Completion
October 1, 2015
Study Completion
November 1, 2015
Last Updated
August 2, 2019
Record last verified: 2019-07