Clinical trials: Mask Ventilation
Obstructive Sleep Apnea
Bioburden and Usability Evaluation of a Nasal Prototype CPAP Mask
AIM AND HYPOTHESIS: The purpose of this study is to monitor the bioburden and impedance characteristics of a prototype mask system and to evaluate the usability of the mask system.
- Trial name
- NCT02255539
- Testing
- Geelong Prototype Mask
- Where
- Australia
- Volunteers
- 42 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
- Trial name
- NCT04063436
- Testing
- New nasal pillows mask with PAP therapy
- Where
- United States
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.
- Trial name
- NCT04011826
- Testing
- Device: Trial nasal mask (F&P)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Oran Park Mask External Clinical Study (3) Marketing Claims Study
The goal of this prospective, randomized, open label, cross over study to assess the seal, comfort, usability, and performance of the prototype Oran Park mask system (referred to as Mask A in this study protocol) in the home…
- Trial name
- NCT06079866
- Testing
- Mask A (Oran Park Mask) then Mask B (Evora Mask), Mask B (Evora Mask) then Mask A (Oran Park Mask)
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- ResMed
Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
Evaluation of the F&P Mask, US, 2026
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
- Trial name
- NCT07826429
- Testing
- F&P Licorice Mask
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Usability Evaluation of Menai CPAP Masks
The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.
- Trial name
- NCT02364375
- Testing
- Menai mask (full face), Menai Standard mask (full face), Menai mask (nasal)
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea
The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep…
- Trial name
- NCT03230877
- Testing
- Toffee full face mask with 'Improved Seal', Toffee full face mask with 'Normal Seal'
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Failure
Safety and Usability of the LUMENA Non-invasive Ventilation Mask
Evaluation of the safety and efficacy of using the Lumena mask, compared to commercially-available, commonly used Oro-nasal masks.
- Trial name
- NCT05479773
- Testing
- Standard NIV mask, Lumena NIV mask
- Where
- Israel
- Volunteers
- 20 people
- Sponsor
- Inspir Labs Ltd.
Healthy Volunteers, Noninvasive Ventilation
The Effect of Mask Design on Transcutaneous Carbon Dioxide in Healthy Volunteers: A Pilot Clinical Investigation
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts transcutaneous CO2 in healthy volunteers on NIV therapy.
- Trial name
- NCT06670482
- Testing
- Non-invasive ventilation (NIV)
- Where
- New Zealand
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Pediatric Nasal Mask Usability Study
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
- Trial name
- NCT01154322
- Testing
- Pixi pediatric mask
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask
This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.
- Trial name
- NCT02942446
- Testing
- Investigative Headgear with CPAP mask
- Where
- New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
Healthy Volunteers
The Effect of Home and Hospital Mask Designs on Respiratory Variables in Healthy Volunteers
The goal of this randomized cross-over study is to investigate whether the design of non-invasive ventilation (NIV) mask impacts respiratory variables in healthy volunteers on NIV therapy.
- Trial name
- NCT07463716
- Testing
- Non-invasive ventilation (NIV)
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea Syndromes
Investigation of the Accordance Between Event Detection of prismaLINE Devices and Polysomnography Using Full Face Masks
Sleep-related breathing disorders are highly prevalent and are usually treated with positive airway pressure (PAP) therapy. To determine the quality of therapy, PAP therapy devices measure the frequency of residual breathing…
- Trial name
- EventLAB FF (NCT06317077)
- Testing
- PAP therapy setting, exclusive use of Löwenstein Medical full face masks
- Where
- Germany
- Volunteers
- 49 people
- Sponsor
- Löwenstein Medical Technology GmbH & Co. KG
Obstructive Sleep Apnea
Evaluation of a Full Face Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the investigative full face mask amongst OSA participants.
- Trial name
- NCT02540603
- Testing
- F&P Jupiter Full Face Mask
- Volunteers
- 15 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Evaluation of the F&P Caramel Nasal Mask, US, 2023
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Caramel nasal mask in a home environment.
- Trial name
- NCT06060717
- Testing
- F&P Caramel
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea
This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F\&P trial full face and nasal mask amongst Obstructive Sleep…
- Trial name
- NCT03142438
- Testing
- F&P Seal Improvement Project
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea (OSA)
Foam Mask - Assessment of Bioburden in a New Mask Seal Material
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP).
- Trial name
- NCT00773721
- Testing
- CPAP mask
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Full-face Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter…
- Trial name
- NCT02938208
- Testing
- Jupiter Full Face Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disorder; Breathing-Related
A Study to Determine Preferences Towards Interface Products
Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol.
- Trial name
- NCT03948152
- Testing
- Standard of Care, Mask Advice Tool
- Where
- 5 sites in United States
- Volunteers
- 310 people
- Sponsor
- Philips Respironics