Clinical trials: Sleep Disordered Breathing (SDB)
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
Sleep Disordered Breathing, Sleep Apnea, Central
Evaluation of the Philips Respironics BiPAP autoSV Devices in Subjects With Sleep Disorders
Comparing two BiPAP autoSV devices in participants with complex sleep apnea and determining if the new device will treat those participants no worse than when compared to its predecessor device.
- Trial name
- NCT01626989
- Testing
- BiPAP auto Advanced, BiPAP auto SV4
- Where
- 3 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Congestive Heart Failure, Left Ventricular Systolic Dysfunction
Sleep-Disordered Breathing in Heart Failure - The SchlaHF-Registry
Objective target of the registry is to investigate the prevalence of SDB as well as the clinical characteristics of patients with and without SDB as well as the predominant type of sdb.
- Trial name
- SchlaHF (NCT01500759)
- Where
- 199 sites in Australia, Germany
- Volunteers
- 6,876 people
- Sponsor
- ResMed
Sleep-Disordered Breathing, Obstructive Sleep Apnea
A Multi-Center Study to Assess the Performance of Saturation Patterns.
A multi-center, prospective, single-visit study designed to acquire physiologic pulse oximeter waveform data during standard polysomnography (PSG) studies performed at multiple different Sleep Lab Centers.
- Conditions
- Sleep-Disordered Breathing, Obstructive Sleep Apnea, Sleep Apnea, Central Sleep Apnea
- Trial name
- NCT00775346
- Where
- 3 sites in United States
- Volunteers
- 92 people
- Sponsor
- Medtronic - MITG
Sleep Disordered Breathing, Congestion, Nasal
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic…
- Trial name
- NCT03105297
- Testing
- Prototype nasal dilator strip, No strip
- Where
- Australia
- Volunteers
- 91 people
- Sponsor
- GlaxoSmithKline
Sleep Disordered Breathing, Sleep Hypopnea
Apnea Hypopnea Index Severity Versus Head Position During Sleep
This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
- Conditions
- Sleep Disordered Breathing, Sleep Hypopnea, Sleep Apnea, Sleep Apnea, Obstructive
- Trial name
- NCT04086407
- Testing
- Dual-axis inclinometer attached to the subject's forehead with tape
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Sleep Systems
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Full-face Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter…
- Trial name
- NCT02938208
- Testing
- Jupiter Full Face Mask
- Where
- 2 sites in New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography.
- Trial name
- NCT02368639
- Testing
- Fisher & Paykel Healthcare PAP Device
- Where
- New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Central, Sleep Disordered Breathing
Respicardia, Inc. Pivotal Trial of the remedē System
The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal…
- Conditions
- Sleep Apnea, Central, Sleep Disordered Breathing, Heart Failure
- Trial name
- NCT01816776
- Testing
- Treatment Group (transvenous stimulation of the phrenic nerve), Control Group (Optimal Medical Therapy)
- Where
- 30 sites in United States, Germany and 1 more
- Volunteers
- 151 people
- Sponsor
- Respicardia, Inc.
Sleep Disordered Breathing
User Preference/Validation Evaluation of the New Philips Respironics Positive Airway Pressure Application
This pilot study is intended to evaluate the acceptance and performance of the DreamMapper application and the Therapist Assist educational tool in naïve patients with Obstructive Sleep Apnea who have been prescribed Positive…
- Trial name
- NCT03748264
- Testing
- Standard of Care, DreamMapper Application, DreamMapper Application with Therapist Assist
- Where
- 5 sites in United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea Syndrome
Brain Oxygenation and Hemodynamics During Sleep in Obstructive Sleep Apnea Sufferers
The goal of this trial is to assess the performance of the OxiplexTS-an absolute near-infrared oximeter-as an instrument to measure brain oxygenation and hemodynamics in sleep medicine as well as in the broader field of…
- Trial name
- NIRS-OSAS (NCT00591591)
- Testing
- OxiplexTS
- Where
- 4 sites in United States
- Volunteers
- 309 people, healthy volunteers welcome
- Sponsor
- ISS, Inc.
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of an Interface 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 interface.
- Trial name
- NCT03725839
- Testing
- F&P Interface
- Where
- 3 sites in New Zealand
- Volunteers
- 33 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep-disordered Breathing, Hypercapnia
Physiological Study to Compare Noninvasive Ventilation (NIV) Masks
Noninvasive ventilation (NIV) is an established therapy that delivers positive pressure to the upper airways to provide respiratory support.
- Trial name
- NCT04926805
- Testing
- CPAP with Mask A, CPAP with Mask B
- Where
- New Zealand
- Volunteers
- 40 people
- Sponsor
- Fisher and Paykel Healthcare
Heart Failure (HF)
SchlaHF-XT-Register. Sleep Disordered Breathing in Heart Failure Register
The SchlaHF XT Registry is a longitudinal study of patients with heart failure (HF). The study aims to understand the importance of diagnosis and treatment of sleep disordered breathing (SDB) on HF with the following questions…
- Trial name
- NCT02301689
- Where
- Germany
- Volunteers
- 4,749 people
- Sponsor
- ResMed
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Acute Decompensated Heart Failure, Sleep Disordered Breathing
Cardiovascular Improvements With MV ASV Therapy in Heart Failure
The aim of the study is to compare the effects of MV targeted ASV in addition to optimized medical therapy versus optimized medical therapy alone at 6 months in patients with acute decompensated HF.
- Trial name
- CAT-HF (NCT01953874)
- Testing
- MV ASV, Optimized Medical Treatment
- Where
- 15 sites in United States, Germany
- Volunteers
- 126 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating…
- Trial name
- NCT00354614
- Testing
- ApneaLink Sleep Screener
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- ResMed
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.
Sleep Disordered Breathing, Sleep Apnea, Central
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3…
- Trial name
- AUTOSV3 (NCT00720213)
- Testing
- Respironics BiPAP autoSV2, Respironics BiPAP autoSV3
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Obstructive Sleep Apnea
Transcend Auto vs Commercially Available Device Clinical Evaluation for Treatment of Obstructive Sleep Apnea (OSA)
The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.
- Trial name
- NCT01799265
- Testing
- Somnetics Transcend Auto, Respironics REMstar Auto with C-Flex
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- Somnetics International, Inc.