Clinical trials: Airway Pressure
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
Study to Predict the Benefits of First-line Humidification Use and Comparison of the Effect of ThermoSmart™ and no Humidification on Adherence
This study aims to investigate the benefits of using first line heated humidification. The primary objective of this research is to determine the effect of high levels of humidification delivered by ThermoSmart™ on CPAP…
- Trial name
- NCT01742949
- Testing
- Heated humidification (ThermoSmart), No Humidification
- Where
- 4 sites in France
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
Comparison Study of the ICON™ Auto Series With and Without SensAwake™ and ThermoSmart™ and Conventional Continuous Positive Airway Pressure in Obstructive Sleep Apnea Patients
A total of 216 patients will be randomized into a partially single blind, randomized, parallel-arm trial to determine whether the ICON™ AT with SensAwake™ and ThermoSmart™ can improve therapy adherence when compared to standard…
- Trial name
- NCT01517763
- Testing
- Conventional CPAP Therapy, Fixed pressure ICON™ without ThermoSmart™, Auto ICON™ with SensAwake™ and ThermoSmart™
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
Positive Airway Pressure Program
Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep.
- Trial name
- NCT02331992
- Testing
- Adherence program
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification.
- Trial name
- NCT00681083
- Testing
- Heated breathing tube (CPAP with ThermoSmart), Non heated breathing tube (CPAP with conventional humidification)
- Where
- 2 sites in United States
- Volunteers
- 26 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
Sleep Apnea, Obstructive
Evaluation of an Algorithm to Detect Sleep and Wake in Continuous Positive Airway Pressure (CPAP)
The purpose of this engineering trial is to develop and validate an algorithm that will deliver Paced Breathing as a ramp feature to obstructive sleep apnea (OSA) subjects using Continuous Positive Airway Pressure (CPAP) therapy.
- Trial name
- PBSW (NCT01031914)
- Testing
- Paced Breathing
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea, Nasal Congestion
Effect of Heated Humidity With Thermosmart™ Compared to an Intranasal Steroid in Improving Compliance and Nasal Symptoms in Patients Using Continuous Positive Airway Pressure
1. CPAP compliance will be significantly higher in both the heated humidity with Thermosmart™ and the nasal steroid phases compared to the double placebo phase. 2.
- Conditions
- Obstructive Sleep Apnea, Nasal Congestion, Sinus Congestion
- Trial name
- Thermosmart (NCT00665977)
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- Clayton Sleep Insititute
Obstructive Sleep Apnea
SLEEP ON Your SIDE (SOS) Study
Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA).
- Trial name
- SOS (NCT04211350)
- Testing
- NightBalance Sleep Position Trainer (SPT), Automatic Positive Airway Pressure (APAP)
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Obstructive Sleep Apnea
Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)
Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data
- Trial name
- NCT02590159
- Testing
- BONGO NASAL EPAP
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InnoMed Healthscience Inc.
Hypoxemia
SuperNO2VA Et Versus Oxygen Face Mask During Deep Sedation
The primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a…
- Trial name
- iOXYGENATE (NCT05175573)
- Testing
- SuperNO2VA Et Nasal Positive Pressure Mask, Supplemental Oxygen Face Mask
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Vyaire Medical
Obstructive Sleep Apnea
Evaluation of a Novel Auto-Adjusting Positive Airway Pressure Algorithm for the Treatment of Obstructive Sleep Apnea Clinical Study
This study aims to assess the effectiveness of an investigational algorithm in the treatment of obstructive sleep apnea.
- Trial name
- NCT06769607
- Testing
- Investigational algorithm, Control algorithm
- Where
- Australia
- Volunteers
- 80 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway…
- Trial name
- REPOSA (NCT06146101)
- Testing
- IHL-42X Low Dose, IHL-42X High Dose, IHL-42X (Optimal Dose)
- Where
- 20 sites in United States
- Volunteers
- 121 people
- Sponsor
- Incannex Healthcare Ltd
Obstructive Sleep Apnea
Association Between Treatment Adherence and Treatment Adherence in Sleep Apnea (SEMSAS)
The objective of the study is to define an optimal threshold of the SEMSA-15 scale for obstructive sleep apnea (OSA) perception in patients with OSA to predict 3-month and 1-year continuous positive airway pressure adherence.
- Trial name
- SEMSAS (NCT04894175)
- Where
- France
- Volunteers
- 302 people
- Sponsor
- Thibaut Gentina
Sleep Apnea Syndromes
The POSAtive Study: Study for the Treatment of Positional Obstructive Sleep Apnea
This study is a prospective, multi-center, randomized crossover of the NightBalance SPT compared to APAP for the treatment of Positional Obstructive Sleep Apnea (POSA).
- Trial name
- NCT03061071
- Testing
- NightBalance Sleep Position Trainer (SPT), Automated Adjusting Positive Airway Pressure (APAP)
- Where
- 11 sites in United States
- Volunteers
- 117 people
- Sponsor
- NightBalance
Obstructive Sleep Apnea
Personal Therapy Comfort Settings Pilot Clinical Study
350 participants will be enrolled in this study. The target population are patients newly diagnosed with OSA and starting CPAP treatment.
- Trial name
- NCT05376137
- Testing
- continuous positive airway pressure (CPAP)
- Where
- Australia
- Volunteers
- 66 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea. The purpose of this study is to (1) evaluate the performance of this system in the efficacy of the treatment in comparison to S8 Escape…
- Trial name
- NCT01171066
- Testing
- Tasman CPAP system
- Where
- Australia
- Volunteers
- 57 people
- Sponsor
- ResMed
Mild-Moderate Obstructive Sleep Disordered Breathing
Non-Inferiority Trial of Acute HFT Versus nCPAP
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
- Trial name
- NCT01860560
- Testing
- High-Flow Therapy, Continuous Positive Airway Pressure
- Where
- United States
- Sponsor
- Vapotherm, Inc.
Sleep Apnea, Obstructive
Novel Auto-continuous Positive Airway Pressure (CPAP) Validation
This single-blind randomised crossover trial aims to compare the efficacy of a novel Auto-CPAP algorithm (SPAP) to conventional CPAP. Up to 50 patients will be recruited from an OSA population, aged over 18.
- Trial name
- NCT01943708
- Testing
- SPAP, CPAP
- Where
- New Zealand
- Volunteers
- 74 people
- Sponsor
- Fisher and Paykel Healthcare