Clinical trials: Sleep Disordered-breathing
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.
Sleep Apnea Syndromes
Comparison of Sleep Disordered Breathing Events Detected by the CPAP Device "prismaLine" With Polysomnography
Evaluation of residual sleep disordered breathing (SDB) under continuous positive airway pressure (CPAP) therapy with comparison of the automatic detected SDB event indices from CPAP machines with manual scored polysomnography…
- Trial name
- NCT04407949
- Testing
- CPAP Treatment
- Where
- Germany
- Volunteers
- 70 people
- Sponsor
- Institut für Pneumologie Hagen Ambrock eV
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
Sleep Apnea, Central Sleep Disordered Breathing
The remedē® System for the Treatment of Central Sleep Apnea in Daily Practice
The aim of this post market study is to assess the impact of sleep-disordered breathing on the well-being of patients according to the treatment chosen, i.e.
- Trial name
- TREAT-CSA (NCT02577445)
- Where
- 10 sites in Germany, Spain
- Volunteers
- 31 people
- Sponsor
- LivaNova
Sleep Disordered Breathing, Congestive Heart Failure
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities.
- Trial name
- NCT02152566
- Testing
- Nasal High flow therapy device
- Where
- 2 sites in New Zealand
- Volunteers
- 6 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
Airway Muscle Activation on Sleep-disordered Breathing Events
The standard for treatment for people suffering from obstructive sleep apnea (OSA) syndrome involves the use of Continuous, or Automatic Positive Airway Pressure (CPAP, APAP) machines, which work by delivering air via tubing and…
- Trial name
- NCT06002061
- Testing
- NovaResp MAPR System
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- NovaResp Technologies Inc
Sleep Apnea, Sleep Apnea Syndromes in Children
Assessing the Performance of Wesper Lab for Sleep Apnea Diagnosis in Pediatric Populations
The goal of this single arm study is to evaluate the effectiveness of Wesper Lab, previously known as TatchSleep Pro, a wireless home sleep test, as a tool to aid in sleep apnea diagnosis as compared to an overnight…
- Conditions
- Sleep Apnea, Sleep Apnea Syndromes in Children, Sleep Apnea Syndromes
- Trial name
- NCT06218186
- Testing
- Medical Device: Wesper Lab Home Sleep Test
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Wesper 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
Pregnancy Related, Sleep
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology in maternal-fetal dyads (and…
- Conditions
- Pregnancy Related, Sleep, Sleep-Disordered Breathing, Sleep Disturbance
- Trial name
- SLeeP AID4 (NCT05376475)
- Testing
- Infrared video-audio camera, Level III home sleep apnea test, Maternal-fetal transabdominal electrocardiographic heart rate monitor
- Where
- Canada
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Central Sleep Apnea, Mixed Sleep Apnea
A Prospective Multicenter Registry of Patients With Sleep Disordered Breathing Treated With DreamStation BiPAP autoSV.
This multi-center observational study will prospectively collect data from patients who have an indication for servo ventilation therapy.
- Conditions
- Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration, Complex Sleep Apnea
- Trial name
- autoSVREGDE (NCT03421704)
- Testing
- DreamStation BiPAP autoSV
- Where
- 9 sites in Germany
- Volunteers
- 129 people
- Sponsor
- Philips Respironics
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
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
Sleep Apnea
AirSense 10 AHI Validation Study
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG).
- Trial name
- NCT03043703
- Testing
- AirSense 10 AutoSet for Her
- Where
- 2 sites in Germany
- Sponsor
- ResMed
Sleep Disordered Breathing, Obstructive Sleep Apnea
An Investigation to Test a Prototype Nasal Mask in the Home Setting
This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is to test the interpretation of user instructions of a prototype nasal mask on participants.
- Trial name
- NCT03752580
- Testing
- User Instructions of novel nasal mask
- Where
- New Zealand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Fisher and Paykel Healthcare
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
Central Sleep Apnea, Heart Failure
Prospective Evaluation of Heart Failure Patients With Central Sleep Apnea
Central sleep apnea (CSA) has been associated with increased mortality and primarily occurs in patients with heart failure (HF).
- Trial name
- NCT01414309
- Where
- 4 sites in United States, Germany
- Volunteers
- 5 people
- Sponsor
- Respicardia, Inc.
Blood Oxygen Desaturations, Sleep-Disordered Breathing
Assessment of the Accuracy of the Non-invasive Wireless Armband Gabi Baby Band for Continuous Vital Parameters Monitoring in Infants and Young Children
During a polysomnography test (PSG) previously prescribed by a physician, the patient also wears the Gaby Baby Band (GBB) during an entire night of sleep.
- Trial name
- WAGSC1 (NCT04886583)
- Testing
- Gabi Baby Band
- Where
- 3 sites in Belgium
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Gabi SmartCare
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
Polysomnography Validation of the Sansa Device
The objective of this study is to evaluate the performance of the Sansa device for the diagnosis of sleep disordered breathing.
- Trial name
- NCT06070389
- Testing
- Sansa device
- Where
- 2 sites in United States
- Volunteers
- 533 people, healthy volunteers welcome
- Sponsor
- Huxley Medical, Inc.