Clinical trials: Sleep Disordered-breathing
Heart Failure, Congestive, Sleep Apnea Syndromes
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.
- Trial name
- NCT00493948
- Testing
- ApneaLink
- Where
- Australia
- Volunteers
- 35 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 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
Sleep Disordered Breathing
Evaluation of Software Enhancements to the Respironics BiPAP autoSV Device Compared to BiPAP S/T Device
This study is being undertaken to collect data from Respironics, Inc's BiPAP autoSV3 and compare with data from Respironics, Inc's BiPAP S/T device, to confirm that the algorithms in the BiPAP autoSV3 device can safely and…
- Trial name
- SV3-ST (NCT01241604)
- Testing
- BiPAP S/T, BiPAP Auto SV3
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
Bradycardia
Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.
- Trial name
- DREAM (NCT01537718)
- Testing
- REPLY 200
- Where
- 5 sites in France, Spain
- Volunteers
- 40 people
- Sponsor
- LivaNova
Sleep-Disordered Breathing
Comparative Assessment of Compumedics Somfit Sleep Monitoring Device
To study whether Somfit is substantially equivalent to the existing approved devices for full polysomnography and home sleep apnea testing
- Trial name
- NCT05647746
- Testing
- Compumedics Somfit HSAT device, WatchPAT HSAT device, Compumedics Grael /E-series PSG system
- Where
- Australia
- Volunteers
- 108 people
- Sponsor
- Compumedics Limited
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
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.
Chronic Heart Failure
Adaptive Servo-ventilation Monitoring Study
Sleep disordered breathing is very common in patients with chronic heart failure with reported prevalence rates of 50-75%. Adaptive Servo-Ventilation (ASV) can be used to treat sleep apnea in these patients.
- Trial name
- NCT02133859
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- ResMed
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
The goal of this observational study is to collect information on the safety and performance of the remedē System in patients with central sleep apnea who are undergoing the remedē System implant procedure.
- Conditions
- Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome, Central Sleep Apnea, Phrenic Nerve Stimulation
- Trial name
- ROSTER (NCT07907068)
- Testing
- Phrenic nerve stimulation
- Volunteers
- 300 people
- Sponsor
- Zoll Medical Corporation
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
Central Sleep Apnea, Complex Sleep Apnea
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions.
- Conditions
- Central Sleep Apnea, Complex Sleep Apnea, Obstructive Sleep Apnea, Mixed Sleep Apnea
- Trial name
- READ-ASV (NCT03032029)
- Testing
- Adaptive Servo-Ventilation
- Where
- 29 sites in Denmark, France and 4 more
- Volunteers
- 847 people
- Sponsor
- ResMed
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
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
Snoring, OSA - Obstructive Sleep Apnea
Serene Sleep Palatal Implant System Clinical Confirmatory Trial in Participants Who Snore or Are Diagnosed With Mild-to-moderate Obstructive Sleep Apnea (OSA).
This clinical investigation is a prospective, non-randomized, parallel-group clinical investigation conducted at two (2) investigative sites.
- Trial name
- NCT07613281
- Testing
- Palatal Implant System
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Serene Sleep, Inc.
Sleep-disordered Breathing (SDB), Sleep Apnea
Validation of the Smart Mask V1 System and Its Measurements of SpO2 and Pulse Rate
The goal of this clinical study is to investigate a new medical device, the Smart Mask V1 System (herein 'Smart Mask'), and particularly its measurements of blood oxygen levels (SpO2) and pulse rate (PR) in healthy adults aged 18…
- Conditions
- Sleep-disordered Breathing (SDB), Sleep Apnea, Sleep Quality
- Trial name
- SMV1: PPG (NCT07086742)
- Testing
- Smart Mask V1 System
- Where
- Belgium
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
Sleep-Disordered Breathing
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders
This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.
- Trial name
- Snoring (NCT00773591)
- Testing
- NT 201, a Botulinum neurotoxin type A, free of complexing proteins
- Sponsor
- Merz Pharmaceuticals GmbH
Heart Failure, Sleep Disordered Breathing
Treatment of Predominant Central Sleep Apnoea by Adaptive Servo Ventilation in Patients With Heart Failure
The purpose of this trial is to evaluate the long-term effects and cost-effectiveness of adaptive servo-ventilation (ASV) on the mortality and morbidity of patients with stable heart failure due to left ventricular systolic…
- Trial name
- Serve-HF (NCT00733343)
- Testing
- Europe: AutoSet CS (USA: VPAP Adapt SV)
- Where
- 267 sites in Australia, Czechia and 9 more
- Volunteers
- 1,325 people
- Sponsor
- ResMed
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, Central Sleep Apnea
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects.
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
- Trial name
- NCT02034175
- Testing
- SomnaPatch, Polysomnography
- Where
- 3 sites in United States
- Volunteers
- 190 people
- Sponsor
- Somnarus Inc