Clinical trials: Apnea, Sleep
Obstructive Sleep Apnea
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
- Trial name
- NCT02357706
- Testing
- APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Patient Perception Questionnaire Validation
Validation of the patient perception questionnaire relating to CPAP use
- Trial name
- NCT02067000
- Testing
- Obstructive Sleep Apnea
- Where
- United States
- Volunteers
- 217 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Sleep Apnea
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
- Trial name
- NCT00906958
- Testing
- Nexus Flow Generator, VPAP Flow Generator 25
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Diabetes Mellitus Type 2
GLYCOSA Study:Effect of PAP Treatment on Glycemic Control in Patients With Type 2 Diabetes
Obstructive Sleep Apnea (OSA) and type 2 diabetes mellitus are two prevalent medical conditions with significant associated cardiovascular and cerebrovascular morbidity and mortality.
- Trial name
- NCT00509223
- Testing
- Positive Airway Pressure therapy, Lifestyle counseling
- Where
- 15 sites in United States, Australia and 1 more
- Volunteers
- 416 people
- Sponsor
- ResMed
Central Sleep Apnea
Post Approval Study of the remedē System
Prospective, single arm cohort study to evaluate the long-term safety, long-term effectiveness, and survival rate in subjects implanted with the remedē System.
- Trial name
- NCT03425188
- Where
- 17 sites in United States, Germany
- Volunteers
- 53 people
- Sponsor
- Respicardia, Inc.
Obstructive Sleep Apnea
DeVilbiss AutoAdjust With SmartFlex Comparative Study
There will be equivalent therapeutic effectiveness between SmartFlex and standard modes when using the DeVilbiss AutoAdjust device.
- Trial name
- NCT01203956
- Testing
- SmartFlex, Standard
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- DeVilbiss Healthcare LLC
Cheyne-Stokes Respiration, Sleep Apnea, Central
Bipap Automatic Servo Ventilation (autoSV) Advanced in Central Apnea Patients
Pilot study testing the Bipap autoSV Advanced Algorithm during full night, in-lab polysomnography (PSG) and 3 months at home on patients with Central Sleep Apnea, Hunter Cheyne Stokes Respiration, or Complex Sleep Apnea.
- Trial name
- NCT01199042
- Testing
- BiPAP autoSV Advanced
- Where
- 3 sites in United States
- Volunteers
- 29 people
- Sponsor
- Philips Respironics
Sleep Apnea
Mapping for Acute Transvenous Phrenic Nerve Stimulation Study
The Mapping for Transvenous Phrenic Nerve Stimulation Study (MAPS) is being conducted to evaluate the feasibility of transvascular stimulation of phrenic nerves via an electrophysiology (EP) catheter advanced into the great veins.
- Trial name
- MAPs (NCT01981590)
- Testing
- Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.
- Where
- 2 sites in Netherlands, Sweden
- Volunteers
- 15 people
- Sponsor
- Medtronic BRC
Obstructive Sleep Apnea, Obesity
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP)…
- Trial name
- SURMOUNT-OSA (NCT05412004)
- Testing
- Tirzepatide
- Where
- 58 sites in United States, Australia and 8 more
- Volunteers
- 469 people
- Sponsor
- Eli Lilly and Company
Obstructive Sleep Apnea (OSA), Post-Traumatic Stress Disorder (PTSD)
Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and…
- Trial name
- NCT02549508
- Testing
- AutoCPAP with SensAwake On, AutoCPAP with SensAwake Off
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Revised Algorithm for Next Generation DeVilbiss Healthcare AutoAdjust Continuous Positive Airway Pressure (CPAP)
The purpose of this protocol is to improve the current FDA-approved continuous positive pressure auto-titration algorithm, including treatment precision, residual disease detection characteristics and phenotyping with the…
- Trial name
- NCT01797705
- Testing
- DeVilbiss AutoAdjust CPAP with revised algorithm
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- DeVilbiss Healthcare LLC
Sleep Apnea
A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software.
- Trial name
- NCT04191668
- Testing
- NightOwl
- Where
- 3 sites in United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Ectosense NV
Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02741635
- Testing
- New Nasal Pillows Mask
- Where
- New Zealand
- Volunteers
- 15 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
The Evaluation of the Toffee 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 of the F\&P Toffee nasal pillows mask amongst obstructive sleep apnea…
- Trial name
- NCT03242148
- Testing
- Toffee Nasal Pillows Mask
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea (OSA)
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance.
- Trial name
- NCT02214238
- Testing
- PAP device
- Where
- New Zealand
- Volunteers
- 49 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
Obstructive Sleep Apnea
TPAP for Comfort in OSA
TheraPAP is a prototype device (with full documented electrical and isolation safety) being developed by SleepRes for the treatment of obstructive sleep apnea (OSA) that can deliver either standard CPAP at a set pressure or what…
- Trial name
- NCT06264128
- Testing
- TPAP, CPAP
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- SleepRes Inc.
Obstructive Sleep Apnea
Study of a Sleep Apnea System for the Treatment of Obstructive Sleep Apnea
This is a prospective study of the Attune Sleep Apnea System for the treatment of obstructive sleep apnea. The objective of the study is to demonstrate safety and effectiveness of the Attune Sleep Apnea System to support FDA…
- Trial name
- ATLAST (NCT01146782)
- Testing
- Attune Sleep Apnea System
- Where
- 6 sites in United States
- Volunteers
- 367 people
- Sponsor
- ApniCure, Inc.