Clinical trials: Sleep Disordered Breathing (SDB)
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
Snoring, Apnea, Obstructive
Dental Appliance to Treat SDB in Children
The clinical hypothesis of this study is that a currently marketed mouthguard may also be able to reduce the symptoms of sleep-disordered breathing in children.
- Conditions
- Snoring, Apnea, Obstructive, Upper Airway Resistance Syndrome, Sleep-Disordered Breathing
- Trial name
- NCT05661747
- Testing
- Vivos Grow/Vivos Way Device
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Vivos BioTechnologies, Inc.
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 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
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA)
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02730273
- Testing
- Trial Nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
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
Unstable Angina, Acute Myocardial Infarction
Prevalence of Sleep Disordered Breathing
A novel technique in identifying unspecified sleep apnea has been developed. This technique uses signals typical acquired from a bedside monitor that is found in critical care environments.
- Conditions
- Unstable Angina, Acute Myocardial Infarction, Congestive Heart Failure
- Trial name
- NCT01011647
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- GE Healthcare
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Mask Seal/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 seal/mask.
- Trial name
- NCT03092921
- Testing
- F&P Mask Seal, F&P Mask
- Where
- New Zealand
- Volunteers
- 18 people
- Sponsor
- Fisher and Paykel Healthcare
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
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
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
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
Sleep Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA…
- Trial name
- NCT03075722
- Testing
- Saturn nasal mask
- Where
- New Zealand
- Volunteers
- 14 people
- Sponsor
- Fisher and Paykel Healthcare
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-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.
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.