Clinical trials: Sleep Disordered-breathing
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
Sleep, Sleep Apnea
Comparison of Dreem to Clinical PSG for Sleep Monitoring in Apnea Patients
This study aims to evaluate the accuracy of apnea detection and automated sleep analysis by the Dreem dry-EEG headband and deep learning algorithm in comparison to the consensus of 5 sleep technologists' manual scoring of a…
- Trial name
- NCT03657329
- Testing
- Dreem
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Dreem
Sleep Apnea, Sleep Apnea, Obstructive
Predictive Accuracy of MATRx Plus in Identifying Favorable Candidates for Oral Appliance Therapy
Obstructive sleep apnea (OSA) is a common disease that is largely un-diagnosed and untreated. Standard treatment for obstructive sleep apnea, nasal continuous positive airway pressure (CPAP), entails use of a nose mask to deliver…
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Disordered Breathing
- Trial name
- NCT03217383
- Testing
- MATRx plus
- Where
- Canada
- Volunteers
- 75 people
- Sponsor
- Zephyr Sleep Technologies
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.
Stillbirth, Infant, Low Birth Weight
UniSA BackOff! Study: Adelaide PrenaBelt Trial
Stillbirth (SB) is a devastating complication of pregnancy and contributes to over 2 million deaths globally every year. Over 20 million infants are born every year with low birth weight (LBW), which is associated with a twenty…
- Conditions
- Stillbirth, Infant, Low Birth Weight, Infant, Very Low Birth Weight, Sleep-Disordered Breathing
- Trial name
- NCT04437407
- Testing
- PB2-1 prototype, PB2-2 prototype, PB2-3 prototype
- Where
- Australia
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Shiphrah Biomedical Inc.
Sleep Disordered Breathing (SDB), Sleep Apnea
Detection of Sleep Stages and Arousals Using Neural Network Classifiers
The objective of this clinical study is to evaluate the accuracy of the Smart Mask V1 System (herein 'Smart Mask') in measuring sleep stages-Stage N1/N2, Stage N3, Rapid Eye Movement (herein 'REM'), and WAKE-arousals, and the…
- Trial name
- SSAM (NCT07136272)
- Testing
- SSAM, Polysomnography, EnsoSleep
- Where
- 3 sites in United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Pathway Medtech, LLC.
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 Disordered Breathing (SDB), Sleep Apnea
Neurostimulation for Sleep Disordered Breathing
This is a first in human study to determine if the Lunair Alpha System is safe and effective for treating moderate to severe sleep disordered breathing.
- Trial name
- ECLIPSE 1 (NCT06883617)
- Testing
- Neuro stimulator Implant
- Where
- Paraguay
- Volunteers
- 45 people
- Sponsor
- Lunair Medical
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 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
Obstructive Sleep Apnea
Nexus Compliance Study
Obstructive sleep apnoea (OSA) is characterised by a partial or complete collapse of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive Airway Pressure (CPAP).
- Trial name
- NCT01013207
- Testing
- CPAP Pre Nexus (S9), Nexus (S9), CPAP Post Nexus (S9)
- Where
- Australia
- Volunteers
- 50 people
- Sponsor
- ResMed
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
Perennial Allergic Rhinitis, Obstructive Sleep Apnea
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
This is a Phase 4 randomized, placebo-controlled, parallel-group, single-center, double-blind study to evaluate the effects of mometasone furoate nasal spray (MFNS) in subjects with Sleep-disordered Breathing (SDB) associated…
- Conditions
- Perennial Allergic Rhinitis, Obstructive Sleep Apnea, Sleep Disorder
- Trial name
- NCT00359216
- Testing
- Mometasone furoate nasal spray
- Volunteers
- 30 people
- Sponsor
- Organon and Co
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.
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
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