Clinical trials: Sleep Disordered Breathing (SDB)
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
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, 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
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 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
Obstructive Sleep Apnea
Transcutaneous Electrical Stimulation in Patients With Obstructive Sleep Apnoea
The objective of this trial is to assess efficacy and compliance of transcutaneous electrical stimulation of the upper airway dilator muscles in patients with obstructive sleep apnoea (TESLA) who do not tolerate continuous…
- Trial name
- TESLA-MICRON (NCT07343362)
- Testing
- ZeusOSA, CPAP
- Volunteers
- 186 people
- Sponsor
- Zeus Sleep Ltd
Sleep Disordered Breathing, Cheyne-Stokes Respiration
Feasibility Study to Determine the Effects of Phrenic Nerve Stimulation in Patients With Periodic Breathing
The purpose of this feasibility study is to determine the effect of stimulating the phrenic nerve to treat periodic breathing (a pattern of breathing characterized by hyperpneas followed by hypopneas or apneas).
- Conditions
- Sleep Disordered Breathing, Cheyne-Stokes Respiration, Sleep Apnea
- Trial name
- NCT00909259
- Testing
- Phrenic stimulation device
- Where
- 5 sites in United States, China and 1 more
- Volunteers
- 50 people
- Sponsor
- Respicardia, Inc.
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.
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
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
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
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.
Sleep Disordered Breathing, Cheyne Stokes Respiration
Chronic Evaluation of Respicardia Therapy
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA).
- Conditions
- Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea
- Trial name
- NCT01124370
- Testing
- remedē (TM) system
- Where
- 13 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Respicardia, Inc.
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, 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
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
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
Sleep Disordered Breathing, Sleep Apnea, Central
Evaluation of Software Enhancements to the Respironics BiPAP Auto Servo Ventilation (AutoSV) Device
This study is being undertaken to collect data from Respironics Inc's BiPAP Auto Servo Ventilation 3 (autoSV3) and compare with data from Respironics, Inc's BiPAP autoSV2, to confirm that the algorithms in the BiPAP autoSV3…
- Trial name
- AUTOSV3 (NCT00720213)
- Testing
- Respironics BiPAP autoSV2, Respironics BiPAP autoSV3
- Where
- 5 sites in United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Philips Respironics
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.
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