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
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
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
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
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
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
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
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
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
A Phase II Pilot Study of the Trillium Full Face Mask
This will be a single-center, open-label randomized crossover design pilot study to evaluate the clinical safety, clinical performance, and clinical benefit of the Trillium full face mask
- Trial name
- NCT06932055
- Testing
- Trillium Full Face Mask, AirFit F20
- Volunteers
- 40 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Sleep Apnea Syndromes
Amara View Benchmark Study
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters.
- Trial name
- NCT06535932
- Testing
- Amara View Minimal Contact Full Face Mask, F40 Minimal Contact Full Face Mask
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Obstructive Sleep Apnea, Sleep Apnea
Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea
This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their…
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea, OSA
- Trial name
- NCT02387476
- Testing
- FRESCA mask first night, CPAP Mask first night
- Where
- 5 sites in United States
- Volunteers
- 47 people
- Sponsor
- FRESCA Medical
Obstructive Sleep Apnea
Evaluation of a Full-Face Mask for the Treatment of Obstructive Sleep Apnea (OSA)
The 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
- NCT03329352
- Testing
- F&P Full-Face Mask
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
A Development Study to Evaluate a Full-Face 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
- NCT03272763
- Testing
- F&P Toffee mask
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Failure, Covid19
Mask Adhesive Institutional Study
To reduce interface leak and aerosol spread, Philips has developed an accessory to non-invasive ventilation(NIV) masks to be used with the Philips AF531 and the PerformaTrak mask on respiratory failure patients.
- Trial name
- NCT04644276
- Testing
- Mask with Mask Adhesive/Arm 1, Mask without Mask Adhesive / Arm 2
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Acute Hypoxemic Respiratory Failure
Lucinactant for Treatment of Acute Hypoxemic Respiratory Failure in Children up to Two Years Old
Treatment with lucinactant, a peptide-containing synthetic lung surfactant, will be evaluated in young children with acute respiratory failure who require mechanical ventilation (life support), to determine if it is safe and if…
- Trial name
- KL4-AHRF-01 (NCT00578734)
- Testing
- Lucinactant
- Where
- 3 sites in United States, Chile
- Volunteers
- 165 people
- Sponsor
- Windtree Therapeutics
Obstructive Sleep Apnea
Laboratory Assessment of Pilairo Q CPAP Mask Performance and Ease of Use.
Participants will undergo a normal sleep study. They will be randomised to use either a FPH Pilairo Q nasal pillow CPAP mask, or another mask.
- Trial name
- NCT02121912
- Testing
- FPH Pilairo Q CPAP mask, Any other market released nasal or nasal-pillow CPAP mask
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Fisher and Paykel Healthcare