Clinical trials: Face Mask
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
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
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
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.
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
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
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
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
Diabetes
A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds
As a consequence of damage to multiple organ systems throughout the course of their disease, diabetic patients suffer a number of chronic complications giving rise to increased morbidity, mortality, and health care costs specific…
- Trial name
- NCT00598871
- Testing
- Thymosin Beta 4 (Tβ4)
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- ReGenTree, LLC
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
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
Noninvasive Ventilation, Respiratory Insufficiency
A Feasibility Study Evaluating the Use of a Non-invasive Ventilation Mask
Evaluate the clinicians assessment of the use of an oro-nasal mask during non-invasive ventilation (non-intubated) with a feasibility study.
- Trial name
- mask (NCT02383719)
- Testing
- Oro-nasal Mask
- Volunteers
- 18 people
- Sponsor
- Convergent Engineering, Inc.
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA…
- Trial name
- NCT03075722
- Testing
- Saturn nasal mask
- Where
- New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
Facial Wrinkles
Safety and Effectiveness of Aquamid as Compared to Restylane for the Aesthetic Treatment of Nasolabial Folds
The purpose of this study is to compare the effectiveness of Aquamid and Restylane in aesthetically enhancing nasolabial folds 6 months after treatment and to evaluate the safety of Aquamid through 12 months after treatment.
- Trial name
- NCT00407914
- Testing
- Aquamid, Restylane
- Where
- United States
- Volunteers
- 315 people, healthy volunteers welcome
- Sponsor
- Contura
Intubation, Tracheostomy
Carbon Dioxide Investigation
The investigational device enables monitoring of EtCO2, FiCO2 and respiration rate values. The purpose of this clinical study is to collect parameter raw data for development, evaluate the operational and functional features of…
- Conditions
- Intubation, Tracheostomy, Laryngeal Mask
- Trial name
- NCT06715410
- Testing
- CO2
- Where
- Finland
- Volunteers
- 42 people
- Sponsor
- GE Healthcare
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
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, 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
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
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