Clinical trials: Mask Ventilation
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)
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02730273
- Testing
- Trial Nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.
- Trial name
- NCT03092921
- Testing
- F&P Mask Seal, F&P Mask
- Where
- New Zealand
- Volunteers
- 18 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea
Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and…
- Trial name
- NCT02297789
- Testing
- Investigative Full Face Mask with Headgear
- Where
- New Zealand
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
Humidity Under Continuous Positive Airway Pressure
Heated humidification in CPAP therapy is often not enough to prevent side effects like dryness of nasal mucosa and xerostomia, especially in cases of mouth breathing or mask leakage.
- Trial name
- NCT01462409
- Testing
- RESMed S9 with humidifier H5i and heated tube Climate Line, CPAP without humidification, CPAP with heated humidification
- Where
- Germany
- Volunteers
- 19 people
- Sponsor
- Institut für Pneumologie Hagen Ambrock eV
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT02894242
- Testing
- F&P Deimos Nasal Pillows Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 22 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of the Toffee 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 mask amongst Obstructive Sleep Apnea (OSA) patients.
- Trial name
- NCT03726346
- Testing
- Toffee Full Face Mask
- Where
- United States
- Volunteers
- 39 people
- Sponsor
- Fisher and Paykel Healthcare
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
COPD (Chronic Obstructive Pulmonary Disease), Obesity Hypoventilation Syndrome (OHS)
The Effect of Mask Design on Ventilation Parameters in COPD and OHS Patients on Long-term Home Non-invasive Ventilation. An Experimental Study.
Chronic obstructive pulmonary disease (COPD) and obesity hypoventilation syndrome (OHS) are respiratory conditions that disrupt normal breathing.
- Trial name
- NCT06972589
- Testing
- Investigational Mask, Conventional mask
- Where
- New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
The Evaluation of a Novel Nasal 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 mask amongst Obstructive Sleep Apnea (OSA)…
- Trial name
- NCT03413098
- Testing
- Nasal CPAP mask
- Where
- 2 sites in New Zealand
- Volunteers
- 30 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep-disordered Breathing (SDB), Sleep Apnea
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18…
- Conditions
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- Trial name
- SMV1: PPG (NCT07086742)
- Testing
- Smart Mask V1 System
- Where
- Belgium
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
Obstructive Sleep Apnea
A Development Study to Evaluate a 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
- NCT03124069
- Testing
- F&P Saturn
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- Fisher and Paykel Healthcare
Intubated Neonates That Require Conventional Ventilation
Comparison of Open Versus Masked Distal EtCO2 Monitoring of Neonates Ventilated With Conventional Ventilation
Primary: The purpose of this study is to assess the clinical implications of continuous distal CO2 monitoring when used for clinical decisions Sub Study: Evaluate the average life time (duration) of Standard Carinal VitaLine set…
- Trial name
- NCT01572272
- Where
- 3 sites in Israel
- Volunteers
- 66 people
- Sponsor
- Oridion
Respiratory Distress Syndrome, Newborn
A Safety and Efficacy Study of Lucinactant for Inhalation in Preterm Neonates 26 to 32 Weeks Gestational Age
This study is to evaluate the safety and efficacy of lucinactant for inhalation in conjunction with nCPAP, in comparison to nCPAP alone, in preterm neonates with RDS, as assessed by the incidence of and time to respiratory…
- Trial name
- NCT04264156
- Testing
- Lucinactant for Inhalation, nCPAP Only
- Where
- 3 sites in Poland
- Volunteers
- 12 people
- Sponsor
- Windtree Therapeutics
Obstructive Sleep Apnea
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure…
- Trial name
- NCT05818540
- Testing
- Eclipse novel CPAP mask, ResMed P-10 mask
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Respiratory Distress Syndrome
The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age
The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal…
- Trial name
- NCT02636868
- Testing
- Lucinactant delivered via investigational delivery device, nCPAP
- Where
- 54 sites in United States, Canada and 6 more
- Volunteers
- 221 people
- Sponsor
- Windtree Therapeutics