Clinical trials: Obstructive Sleep Disordered Breathing
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
Validation of the ApneaLink Sleep Screener for Obstructive Sleep Apnea (OSA)
The primary endpoints for this study are that the AL validation will 1) achieve a sensitivity of greater than 80% for AHI values greater than or equal to 15, and 2) demonstrate a correlation coefficient of r=0.75 indicating…
- Trial name
- NCT00354614
- Testing
- ApneaLink Sleep Screener
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- ResMed
Mild-Moderate Obstructive Sleep Disordered Breathing
Non-Inferiority Trial of Acute HFT Versus nCPAP
Order randomized crossover non-inferiority study evaluating the acute efficacy of High Flow Therapy (HFT) as compared to nasal Continuous Positive Airway Pressure therapy (CPAP) in the management of apnea / hypopnea index (AHI).
- Trial name
- NCT01860560
- Testing
- High-Flow Therapy, Continuous Positive Airway Pressure
- Where
- United States
- Sponsor
- Vapotherm, Inc.
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
Central Sleep Apnea, Complex Sleep Apnea
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Phase 1: The European ASV Registry (short name) will investigate the use of Adaptive Servo-Ventilation in non-heart failure conditions.
- Conditions
- Central Sleep Apnea, Complex Sleep Apnea, Obstructive Sleep Apnea, Mixed Sleep Apnea
- Trial name
- READ-ASV (NCT03032029)
- Testing
- Adaptive Servo-Ventilation
- Where
- 29 sites in Denmark, France and 4 more
- Volunteers
- 847 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.
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.
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.
Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF)
Clinical Trials for Elderly Patients With Multiple Disease
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other…
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)
- Trial name
- CHROMED (NCT01960907)
- Testing
- CHROMED monitoring system
- Where
- 6 sites in Estonia, Slovenia and 3 more
- Volunteers
- 312 people
- Sponsor
- Restech Srl
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, 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 Disordered Breathing, Obstructive Sleep Apnea
The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea
This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.
- Trial name
- NCT03156413
- Testing
- F&P nasal mask
- Where
- New Zealand
- Volunteers
- 12 people
- Sponsor
- Fisher and Paykel Healthcare
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
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.
Obstructive Sleep Apnea Syndrome
Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients
To study the effect of Xyrem (9 g), Xyrem (9 g) plus modafinil 200 mg administered the morning prior to Xyrem, positive control (zolpidem 10 mg), and placebo on the frequency and outcome of events of sleep-disordered breathing in…
- Trial name
- NCT00086281
- Testing
- Xyrem (X), Zolpidem (Z), Modafinil (M)
- Where
- 2 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Jazz Pharmaceuticals
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 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
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 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, Sleep Hypopnea
Apnea Hypopnea Index Severity Versus Head Position During Sleep
This study evaluates the correlation of the position of the head during sleep, independent of the position of the torso, and the severity of apnea hypopneas in obstructive sleep apnea.
- Conditions
- Sleep Disordered Breathing, Sleep Hypopnea, Sleep Apnea, Sleep Apnea, Obstructive
- Trial name
- NCT04086407
- Testing
- Dual-axis inclinometer attached to the subject's forehead with tape
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Sleep Systems