Clinical trials: Continuous Positive Airway Pressure
Obstructive Sleep Apnea
TheraPAP Equivalence Crossover Study
The present study, TheraEquivalence, is a Phase 2 crossover study designed to examine the efficacy and safety of TheraPAP (TPAP) vs. CPAP alone in the treatment of OSA.
- Trial name
- NCT06238362
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- SleepRes Inc.
Obstructive Sleep Apnea Syndrome
Evaluation of a New Medical Device AL539 in Patients With Obstructive Apneas Sleep Syndrome
Continuous Positive Airway Pressure (CPAP) is the standard treatment in patients with Obstructive Sleep Apnea Syndrome (OSAS). The goal of the study is to evaluate CPAP treatment duration recorded by the AL539 during attended…
- Trial name
- AL539 (NCT01441622)
- Testing
- AL539 (SRETT)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Air Liquide Santé International
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous…
- Trial name
- TESLA-MICRON (NCT07343362)
- Testing
- ZeusOSA, CPAP
- Volunteers
- 186 people
- Sponsor
- Zeus Sleep Ltd
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
Obstructive Sleep Apnea
Prospective Cohort Study of Patients Intolerant to High Pressure Under Continuous Positive Airway Pressure Treated With Bilevel Positive Airway Pressure as Second-line Therapy.
Prospective observational study of obstructive Sleep Apnea patients treated with Bilevel Positive Airway Pressure: AirCurve 10 VAutoTM
- Trial name
- PoP IN VAuto (NCT02930460)
- Where
- 8 sites in France
- Volunteers
- 30 people
- Sponsor
- ResMed
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
Quality of Life
Consequences of Respiratory Devices on Caregivers (CAP2)
The promoter of the study will conduct a monocentric cohort study that aim to evaluate the consequences of home respiratory devices on patient caregivers' quality of life.
- Trial name
- CAP2 (NCT04632836)
- Testing
- quality of life questionnaires
- Where
- France
- Volunteers
- 350 people, healthy volunteers welcome
- Sponsor
- Asten Sante
Obstructive Sleep Apnea
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an…
- Trial name
- NCT04718142
- Testing
- vNEP
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Somne, LLC
Obstructive Sleep Apnea
Effects of Humidity (During CPAP Treatment) on Mucociliary Clearance in Patients With Obstructive Sleep Apnea
That the level of humidification delivered to patients during CPAP treatment will alter the subjects mucociliary clearance rate and related mucus properties.
- Trial name
- CIA-6 (NCT00790166)
- Testing
- CPAP + ThermoSmart™ humidity, CPAP + Conventional humidity, CPAP + No added humidity
- Where
- Brazil
- Volunteers
- 4 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea (OSA)
Palatal Implants in Combination With Continuous Positive Airway Pressure to Treat Obstructive Sleep Apnea
The study will be done for the following purposes: to see if Pillar implants in combination with CPAP therapy can help people with their OSA by decreasing the CPAP pressures to find out if receiving Pillar implants will increase…
- Trial name
- Pillar-CPAP (NCT00730041)
- Testing
- Pillar Palatal Implant System
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- Medtronic Xomed, Inc.
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 Apnea, Obstructive
SensAwake™ Sleep Quality Trial
The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake.
- Trial name
- SASQT (NCT00811213)
- Testing
- SleepStyle 200 Auto Series with SensAwake, SleepStyle 200 Auto Series with out SensAwake
- Where
- Australia
- Volunteers
- 45 people
- Sponsor
- Fisher and Paykel Healthcare
Apnea (Central and Obstructive)
MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)
A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence.
- Trial name
- MEntA Program (NCT07258264)
- Testing
- Motivational Interviewing (MI), Competency-based learning
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Air Liquide Healthcare Spain
Respiratory Failure
Prevention of Pressure Ulcers in Patients Under Non-Invasive Mechanical Ventilation
This study aims to test direct application of the Non-Invasive Mechanical Ventilation -NIVM- mask or interface as the most efficient intervention to prevent Pressure Ulcers (PU), compared with other three usual preventive…
- Trial name
- PUPPVMNI (NCT02526862)
- Testing
- Allevyn Thin®, Askina Transorbent Border®, Linovera®
- Where
- Spain
- Volunteers
- 152 people
- Sponsor
- B. Braun Medical SA
Sleep Apnea, Obstructive, Primary Open-angle Glaucoma
IOP Fluctuations in Patients With Sleep Apnea With or Without Primary Open Angle Glaucoma Using Positive Airway Pressure
Sleep apnea is characterized by repetitive episodes of decreased or interrupted airflow in the upper airways during sleep. Obstructive sleep apnea syndrome (OSAS) is the most common sleep-related breathing disorder and is…
- Trial name
- NCT01560975
- Testing
- SENSIMED Triggerfish®
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Sensimed AG
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
Obstructive Sleep Apnea
KPAP vs EPR for Efficacy
The KPAP EPR is a randomized, crossover study in which treatment efficacy will be compared between SleepRes CPAP + KPAP and ResMed CPAP + EPR.
- Trial name
- NCT07530523
- Testing
- APAP + KPAP, APAP + EPR
- Volunteers
- 24 people
- Sponsor
- SleepRes Inc.
OSA
Impact of Patient Involvement in Alerts Management of Telemonitoring CPAP
Adherence to CPAP determines the expected benefits of the treatment. A dose-benefit relationship has been demonstrated for both functional and cardiovascular benefits.
- Trial name
- NCT05960175
- Testing
- New telemonitoring approach using 2 connected devices : Scanwatch connected watch + Asten&masanté application
- Where
- 11 sites in France
- Volunteers
- 556 people
- Sponsor
- Asten Sante
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
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