Clinical trials: Sleep-Disordered Breathing
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
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
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.
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
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 (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, 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
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 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
Insomnia, Sleep-Disordered Breathing
CPAP vs ASV for Insomnia
The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.
- Trial name
- P2P (NCT02365064)
- Testing
- AirCurve 10 ASV
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- ResMed
Sleep Disordered Breathing, Obstructive Sleep Apnea
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients
The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.
- Conditions
- Sleep Disordered Breathing, Obstructive Sleep Apnea, Central Sleep Apnea
- Trial name
- NCT00922168
- Where
- 2 sites in United States
- Volunteers
- 146 people
- Sponsor
- Cleveland Medical Devices Inc
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, 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 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
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