Clinical trials: Sleep Disordered Breathing
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
Breathing-Related Sleep Disorder
A Pilot Study to Assess the Effects of a Novel Application of Averaged Volume Assured Pressure Support Ventilation (AVAPS-AE) Therapy on Re-hospitalization in Patients With Sleep-Disordered Breathing With Co-morbid COPD
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- STOP-BBACK (NCT02446769)
- Testing
- AVAPS-AE Non-invasive ventilation therapy
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Philips Respironics
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of an Alternative Sizing Model in Comparison of a Conventional Sizing Model for Full Face Masks in the Treatment of OSA in Terms of Performance and Comfort
The investigation is a prospective non-blinded and semi-randomized clinical investigation. The investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a…
- Trial name
- NCT02851628
- Testing
- Alternative sizing model based trial mask, Prototype Full Face Mask
- Where
- 4 sites in New Zealand
- Volunteers
- 20 people
- Sponsor
- Fisher and Paykel Healthcare
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.
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 Disorder (Disorder)
US Development and Evaluation Study of a Patch-Based PSG System
The purpose of this study is continue the development and evaluation of the Onera system as well as the procedures and best practices for dispensing, instruction, use and reportability of results.
- Trial name
- NCT06881667
- Testing
- Home PSG Assessment
- Where
- 2 sites in United States
- Volunteers
- 70 people
- Sponsor
- Onera BV
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
ApneaLink Air Home Sleep Testing (HST) Device Validation Study
This study compares the diagnostic capability of a home sleep apnea testing device to polysomnography.
- Trial name
- NCT03470493
- Testing
- ApneaLink Air
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ResMed
Sleep Apnea Syndromes
Sleep Disordered Breathing and Chronic Pain
The purpose of this study is to evaluate positive pressure in patients with chronic pain taking opioid medications who have sleep disordered breathing.
- Trial name
- NCT01457014
- Testing
- servo ventilation auto, Continuous positive airway pressure, servo ventilation manual
- Where
- 4 sites in United States
- Volunteers
- 88 people
- Sponsor
- Philips Respironics
Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF)
Clinical Trials for Elderly Patients With Multiple Disease
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other…
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)
- Trial name
- CHROMED (NCT01960907)
- Testing
- CHROMED monitoring system
- Where
- 6 sites in Estonia, Slovenia and 3 more
- Volunteers
- 312 people
- Sponsor
- Restech Srl
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
Chronic Heart Failure, Central Sleep Apnea
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS)
The purpose of FACE study is to provide in routine practice complementary long-term data on the mortality and morbidity of Chronic Heart Failure (CHF) patients with Central Sleep Apnea eligible for Adaptative Servo-Ventilation…
- Trial name
- FACE (NCT01831128)
- Testing
- ASV Treatment
- Where
- 18 sites in France
- Volunteers
- 509 people
- Sponsor
- ResMed
Sleep Disordered Breathing
Oxygen Monitoring of Patients After Surgery on the Hospital General Care Floor
The pain medication given after major surgery may cause some patients to stop breathing for periods of time especially at night time. An oxygen monitor may reflect this abnormal breathing pattern.
- Trial name
- NCT01082575
- Testing
- Oxygen Monitoring
- Where
- 3 sites in United States
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
Sleep Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing (SDB)
This is a study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 2 (NCT07243405)
- Testing
- Neuro stimulator implant
- Where
- Panama
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
Heart Failure, Sleep Disorder
Substudy on the Mechanistic Plausibility of the Clinical Benefits of Adaptive Servo-ventilation
The purpose of this study is to assess changes in left ventricular performance using echocardiography as well as ventricular remodelling, changes in sleep and changes in mood, anxiety and cognitive functions occurring as a result…
- Conditions
- Heart Failure, Sleep Disorder, Cheyne Stokes Respiration
- Trial name
- MS (NCT01164592)
- Testing
- adaptive servoventilation (ASV)
- Where
- 94 sites in Australia, Czechia and 6 more
- Volunteers
- 312 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.
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, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT03156413
- Testing
- F&P nasal mask
- Where
- New Zealand
- Volunteers
- 12 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.