Clinical trials: Mask Ventilation
Obstructive Sleep Apnea
Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
Each Whitsunday mask or AirFit N30i Quiet mask is worn for 7 nights. The overall purpose of this study is to evaluate the performance of the Whitsundays nasal mask system (a prototype mask) compared to the ResMed AirFit N30i…
- Trial name
- NCT05255744
- Testing
- Positive Airway Pressure (PAP) Therapy
- Where
- Singapore
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
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
Sleep-disordered Breathing, Hypercapnia
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support.
- Trial name
- NCT04926805
- Testing
- CPAP with Mask A, CPAP with Mask B
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Respiratory Insufficiency, Respiratory Failure
Vela Generation II: Usability and Performance of a Non-Invasive Ventilation Mask.
Study Overview The goal of this clinical trial is to learn whether an improved non invasive ventilation mask with airway washout can reduce how often people need to breathe and perform as well as standard NIV masks when used with…
- Trial name
- NCT07484802
- Testing
- NIV interface with airway washout
- Volunteers
- 60 people
- Sponsor
- Fisher and Paykel Healthcare
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
Investigative Headgear With 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 2-4 weeks.
- Trial name
- NCT02323035
- Testing
- Headgear
- Where
- New Zealand
- Volunteers
- 23 people, healthy volunteers welcome
- 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
Obstructive Sleep Apnea
PAP Systems External Clinical Studies (ECS)
This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.
- Trial name
- NCT06562205
- Testing
- PAP System A (with Amalfi) then PAP System B (with CLA11), PAP System B (with CLA11) then PAP System A (with Amalfi)
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- ResMed
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
Sleep Disordered Breathing (SDB), Sleep Apnea
Detection of Sleep Stages and Arousals Using Neural Network Classifiers
The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1/N2, Stage N3, Rapid Eye Movement (herein 'REM'), and WAKE-arousals, and the…
- Trial name
- SSAM (NCT07136272)
- Testing
- SSAM, Polysomnography, EnsoSleep
- Where
- 3 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
Acute Hypercapnic Respiratory Failure, Acute Hypoxemic Respiratory Failure
Pilot Physiological Evaluation of an Investigational Mask with Expiratory Washout.
The goal of this pilot randomized cross-over study is to compare the effect of a full-face mask with expiratory washout to a conventional full face mask on non-invasive ventilation (NIV) in patients with acute hypercapnic, and…
- Trial name
- NCT06007495
- Testing
- Investigational full-face mask with expiratory washout, Conventional full-face mask - single-limb, Conventional full-face mask - dual-limb
- Where
- 2 sites in Canada
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Chronic Respiratory Conditions, Obstructive Sleep Apnea (OSA)
Evaluation of 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 mask in a home environment.
- Trial name
- NCT07847814
- Testing
- F&P Mask
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Obesity Hypoventilation Syndrome
Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.
- Trial name
- NCT02486380
- Testing
- Toffee full face mask/toffee nasal mask
- Where
- New Zealand
- Volunteers
- 4 people
- Sponsor
- Fisher and Paykel Healthcare
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
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a…
- Trial name
- NCT02851628
- Testing
- Alternative sizing model based trial mask, Prototype Full Face Mask
- Where
- 4 sites in New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Post Market Clinical Follow up of ResMed Mask Systems
Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
- Trial name
- NCT05262439
- Testing
- New generation CPAP mask
- Where
- Australia
- Volunteers
- 500 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
The Evaluation of a Novel 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 with the F\&P trial nasal pillows mask amongst Obstructive Sleep Apnea…
- Trial name
- NCT03605485
- Testing
- Nasal Pillows CPAP mask
- Where
- New Zealand
- Volunteers
- 9 people
- Sponsor
- Fisher and Paykel Healthcare