Clinical trials: sponsored by ResMed
Obstructive Sleep Apnea Syndrome
Clinical Impact of 2 Types of Mandibular Retention Devices - Narval O.R.M CadCam Design vs Narval O.R.M Traditional Design - on Obstructive Sleep Apnea (OSA) Therapy: ESTAMPS Study
ESTAMPS is a randomized clinical trial with a crossover design: Main objective is to compare impact of 2 different Mandibular Retention Device (MRD) designs (Narval MRD CadCam (CC) design vs Narval MRD traditional (trad) design)…
- Trial name
- ESTAMPS (NCT02755662)
- Testing
- Mandibular Retention Device
- Where
- France
- Volunteers
- 12 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
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
Chronic Obstructive Pulmonary Disease
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program
This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on: the amount of daily physical activity Quality of life The 6-minute walk distance Time to…
- Trial name
- NCT02100709
- Testing
- BiLevel Noninvasive Ventilation
- Where
- Germany
- Volunteers
- 14 people
- Sponsor
- ResMed
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
Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis)
Effectiveness of Adaptive Servoventilation (ASV) in Patients With Central Sleep Apnea Due to Chronic Opioid Use
Prospective, randomized, blinded, cross-over study assessing the effectiveness of adaptive servo-ventilation (ASV) in treating patients who have obstructive sleep apnea (OSA) complicated by central sleep apnea (CSA) due to the…
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea (Diagnosis), Chronic Opioid Use
- Trial name
- NCT01462084
- Testing
- Adaptive servo-ventilation (ASV), Bi-Level PAP
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- ResMed
Diastolic Heart Failure
Positive Airway Pressure Therapy Study in Sleep Apnea and Diastolic Heart Failure
This is a multicenter, prospective, randomized clinical trial (pilot study). 20 participants with diastolic heart failure will be assigned to ventilation therapy (AutoSet CS ™ ASV device; therapy group).
- Trial name
- ParadiseHF (NCT02254382)
- Testing
- Adaptive servo ventilation (ASV)
- Where
- 2 sites in Germany
- Volunteers
- 2 people
- Sponsor
- ResMed
Central Sleep Apnea, Heart Failure
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)
The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea.
- Trial name
- FACE (NCT02356367)
- Testing
- telemonitoring
- Where
- 3 sites in France
- Sponsor
- ResMed
Obstructive Sleep Apnea
AutoSet for Her Clinical Trial Protocol
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients.
- Trial name
- NCT01826513
- Testing
- Standard AutoSet algorithm, Modified AutoSet algorithm
- Where
- Australia
- Volunteers
- 25 people
- Sponsor
- ResMed
Periodic Breathing, Breathing-Related Sleep Disorder
Modified Adaptive Servoventilation (ASV) Compared to Conventional ASV
This study will determine if modified adaptive servoventilation (ASV) is as effective as the conventional ASV in treating periodic breathing.
- Trial name
- NCT01405313
- Testing
- Modified Adaptive Servoventilation Device, Conventional Adaptive Servoventilation device
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
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
Respiratory Failure, Neuromuscular Disease
Ventilator Monitoring in Early Exacerbation Detection
The aim of this study is to determine whether respiratory disease exacerbations (a sudden worsening of symptoms) can be predicted by variables that are monitored by non-invasive ventilators (small machines that assist breathing)…
- Conditions
- Respiratory Failure, Neuromuscular Disease, Chest Wall Disorder, Chronic Obstructive Pulmonary Disease
- Trial name
- NCT01644162
- Testing
- iVAPS ventilation
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- ResMed
OSA
Nasal Pillows vs. Nasal Masks at High CPAP Pressure
The aim of this evaluation is to test: 1. Whether using nasal pillows at high pressures has comparable outcomes to nasal masks 2. Patient mask type preferences at high pressures
- Trial name
- NCT01690923
- Testing
- Nasal mask, Pillows mask
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Healthy
The Evaluation of a New Sleep Algorithm
A new device is being developed to screen for sleep-breathing disorders. Within this device is a new software algorithm which will determine sleep/wake states.
- Trial name
- NCT01925430
- Testing
- Screening device, Comparative product
- Where
- Australia
- Volunteers
- 36 people, healthy volunteers welcome
- 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
Obstructive Sleep Apnea
Evaluation of Acclimate Feature for Positive Airway Pressure (PAP) Therapy
The purpose of the study is to evaluate if using the Acclimate feature at the beginning of Positive Airway Pressure (PAP) therapy results in patients using their PAP therapy at least as long as they would standard therapy.
- Trial name
- NCT01421654
- Testing
- S9 Elite with Acclimate, S9 Elite
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- ResMed
Complex Sleep Apnea Syndrome
Complex Sleep Apnea Syndrome (CompSAS) Resolution Study
The purpose of this study is to determine whether adaptive servo-ventilation (ASV) or continuous positive airway pressure (CPAP) is better at treating complex sleep apnea over time.
- Trial name
- CompSAS (NCT00915499)
- Testing
- VPAP Adapt SV
- Where
- 6 sites in United States
- Volunteers
- 66 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Pediatric Nasal Mask Usability Study
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
- Trial name
- NCT01154322
- Testing
- Pixi pediatric mask
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Performance of the Salt Lake Mask System
Assessment of the performance of the Salt Lake mask system acting as a patient interface in the provision of PAP therapy. This study will assess the suitability of this mask system in its current form for use.
- Trial name
- NCT01395693
- Testing
- Salt Lake mask system
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Heart Failure, Sleep Apnea Syndromes
Mechanisms of Action of Adaptive Servoventilation
It is known that a significant proportion of patients with heart failure have sleep disordered breathing (SDB). Some of these patients will have Central Sleep Apnoea which is one form of SDB.
- Trial name
- NCT00976417
- Where
- United Kingdom
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- ResMed