The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
NCT ID: NCT02741635
Last Updated: 2024-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2016-04-30
2016-05-31
Brief Summary
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A total number of 15 participants who currently use a nasal pillows mask will be recruited for the trial. Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI).
Participants will undergo an overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab.
The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the overnight in-lab study.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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New Nasal Pillows Mask
Participants to use nasal pillows mask one night in lab overnight polysomnography.
New Nasal Pillows Mask
Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Interventions
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New Nasal Pillows Mask
Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
Eligibility Criteria
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Inclusion Criteria
* Able to give consent
* AHI ≥ 5 on diagnostic night
* Prescribed a CPAP device after successful OSA diagnosis
* Existing nasal pillows mask user
Exclusion Criteria
* Patients who are in a coma or a decreased level of consciousness.
* Anatomical or physiological conditions making APAP therapy inappropriate
* Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
* Current diagnosis of CO2 retention
* Pregnant or may think they are pregnant.
18 Years
ALL
No
Sponsors
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Fisher and Paykel Healthcare
INDUSTRY
Responsible Party
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Principal Investigators
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Bhavi Ogra, BSc
Role: PRINCIPAL_INVESTIGATOR
Sponsor Employee
Locations
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Fisher & Paykel Healthcare Ltd
Auckland, East Tamaki, New Zealand
Countries
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Other Identifiers
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CIA-190
Identifier Type: -
Identifier Source: org_study_id
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