Clinical trials: Mask Ventilation
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea (OSA)
Vent Flow Study of Prototype Nasal CPAP Mask
As continuous positive airway pressure is the treatment choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance of a new mask system with diffuse vent technology.
- Trial name
- GVFECT (NCT02805777)
- Testing
- CPAP mask
- Sponsor
- ResMed
Acute Respiratory Distress Syndrome, Noninvasive Ventilation
Helmet vs Face Mask in Patients With Acute Respiratory Distress Syndrome
The objective of this study is to evaluate the efficacy of noninvasive ventilation with helmet in reducing endotracheal intubation rates in comparison with Noninvasive Ventilation (NIV) facemask among patients with Acute…
- Conditions
- Acute Respiratory Distress Syndrome, Noninvasive Ventilation, Corona Virus Disease, Acute Respiratory Failure
- Trial name
- NCT04507802
- Testing
- Non invasive ventilation via helmet
- Where
- Qatar
- Volunteers
- 60 people
- Sponsor
- Hamad Medical Corporation
Obstructive Sleep Apnea
Performance of the Salt Lake Mask System
Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.
- Trial name
- NCT01395693
- Testing
- Salt Lake mask system
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT03156413
- Testing
- F&P nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows 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 the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02741635
- Testing
- New Nasal Pillows Mask
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea, Respiratory Insufficiency
Study of the Usability and Efficacy of a New Pediatric CPAP Mask
This study will evaluate a newly developed pediatric mask (known as Pixi) on children aged 2-7 using continuous positive airway pressure (CPAP), or Non-invasive ventilation (NIV) treatment.
- Trial name
- NCT01312948
- Testing
- Prototype mask (known as Pixi)
- Where
- Australia
- Volunteers
- 6 people
- Sponsor
- ResMed
Patient Ventilator Interactions
Analysis and Evaluation of Asynchronies Between NIV Patients and Their Prisma VENT or LUISA Ventilator
This study aims to analyze the types, rates, and patterns of disturbances between the breathing of patients receiving non-invasive ventilation and their ventilator (patient-ventilator asynchronies, PVA) during routine therapy…
- Trial name
- NCT07768748
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Löwenstein Medical Technology GmbH & Co. KG
Obstructive Sleep Apnea
The Evaluation of the Toffee Nasal Pillows 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 of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea…
- Trial name
- NCT03242148
- Testing
- Toffee Nasal Pillows Mask
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.
- Trial name
- NCT05573763
- Testing
- F&P Toffee
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnoea (OSA)
Assessment of the Performance of a New Reduced Noise Mask Vent
As continuous positive airway pressure is the treatment of choice for OSA, a mask is vital in ensuring the effectiveness of therapy delivery. The study will evaluate the performance and usability of the new mask vent.
- Trial name
- NCT01575210
- Testing
- CPAP mask
- Where
- Australia
- Volunteers
- 31 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Analysis of a New Mask for Positive Airway Pressure (PAP) Device Users
BACKGROUND AND AIMS Continuous positive airway pressure (CPAP) is an effective therapy to treat sleep apnea. Sleep apnea is a condition where the airways collapse when the patient is asleep.
- Trial name
- NCT01847846
- Testing
- CPAP mask - prototype
- Where
- Australia
- Volunteers
- 23 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022
This clinical investigation is designed to assess the F\&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery.
- Trial name
- NCT05496062
- Testing
- F&P Toffee Nasal and Toffee Nasal Pillows Masks
- Where
- 2 sites in United States
- Volunteers
- 91 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea in New Zealand
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…
- Trial name
- NCT02541214
- Testing
- Trial Nasal Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 39 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
PAP Systems Internal Clinical Studies (ICS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems to guide product development.
- Trial name
- NCT06173050
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
Respiratory Failure
NIV Mask Assessment of Usability and Performance
Assessment of usability, perceived comfort and performance of a NIV mask in the hospital environment.
- Trial name
- NCT05059288
- Testing
- Investigational Non Invasive Ventilation Mask
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare
Positive Airway Pressure Therapy, Obstructive Sleep Apnea
F&P Toffee Full Face Mask Clinical Trial, NZ, 2020
This will be a prospective, multi-arm, randomized, and non-blinded clinical trial designed to evaluate the performance, comfort, and usability of the Toffee full face mask amongst participants who have been prescribed PAP therapy…
- Trial name
- NCT04615832
- Testing
- Toffee Full Face Mask
- Where
- 3 sites in New Zealand
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Whitsundays (Nasal) Mask Take Home Study (90 Days)
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea.
- Trial name
- NCT06036329
- Testing
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion, Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask
- Trial name
- NCT02972970
- Testing
- Aveera
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Metamason
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Nasal Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants.
- Trial name
- NCT03752580
- Testing
- User Instructions of novel nasal mask
- Where
- New Zealand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare