Clinical trials: Obstructive Sleep Apnea Syndrome (OSAS)
Obstructive Sleep Apnea of Adult
Real World Experiences of the iNAP® Lite in OSA Adults in Taiwan
A Prospective, Observational, Post-market Surveillance Study to Evaluate the Long-term Safety and Efficacy of the iNAP® Lite Sleep Therapy System in Adults with Obstructive Sleep Apnea
- Trial name
- NCT03559322
- Testing
- iNAP® Lite Sleep Therapy System
- Where
- Taiwan
- Volunteers
- 76 people
- Sponsor
- Somnics, Inc.
Obstructive Sleep Apnea, OSA
Early Feasibility Study of Transcutaneous Upper Airway Stimulation in Obstructive Sleep Apnea
Early feasibility study to estimate the functionality of a novel intervention based on non-invasive transcutaneous electrical stimulation of the hypoglossal nerve to reduce the Apnea Hypopnea Index (AHI).
- Trial name
- NCT05881512
- Testing
- Transcutaneous Upper Airway Stimulation Device
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Somnial Inc
Sleep Apnea, Obstructive
Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA.
The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies.
- Trial name
- ACCCESS (NCT05592002)
- Testing
- Genio System
- Where
- 16 sites in United States
- Volunteers
- 124 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
Whitsundays (Nasal) Mask Take Home Study (90 Days)
The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea.
- Trial name
- NCT06036329
- Testing
- Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion, Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea
This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen…
- Trial name
- NCT01078207
- Where
- 2 sites in Canada
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
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
Obstructive Sleep Apnea
Pediatric Nasal Mask Usability Study
The purpose of the study is to demonstrate the effectiveness of a pediatric mask in treating obstructive sleep apnea (OSA) in a pediatric population.
- Trial name
- NCT01154322
- Testing
- Pixi pediatric mask
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)
The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst.
- Trial name
- NCT01010438
- Where
- 3 sites in Israel
- Volunteers
- 59 people
- Sponsor
- Oridion
Sleep Apnea
Modified AutoSet Device vs Existing AutoSet Device, the Assessment of Efficacy and Subjective Comfort of the Treatment.
The purpose of this study is to determine if the performance of the modified AutoSet device is equivalent or better than the existing AutoSet device (VPAP Auto) in the efficacy of the treatment and the subjective comfort.
- Trial name
- NCT00906958
- Testing
- Nexus Flow Generator, VPAP Flow Generator 25
- Where
- Australia
- Volunteers
- 20 people
- Sponsor
- ResMed
Cardiac Diseases, Muscular Weakness
Biomarker for Pompe Disease (BioPompe)
Development of a new MS-based biomarker for the early and sensitive diagnosis of Pompe disease from blood (plasma)
- Conditions
- Cardiac Diseases, Muscular Weakness, Hepato-splenomegaly, Lung Disease
- Trial name
- BioPompe (NCT01457443)
- Where
- 4 sites in Germany, India and 1 more
- Sponsor
- CENTOGENE GmbH Rostock
Obstructive Sleep Apnea
A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose
BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways.
- Trial name
- NCT04872387
- Testing
- BAY2586116
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Obstructive Sleep Apnea (OSA)
Correlation Endoscopic View of Airway Obstruction With RRa in OSA Patients Under DEX Monitored With SedLine EEG
Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA.
- Trial name
- NCT02639884
- Testing
- SedLine EEG, RRa monitoring
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Masimo Corporation
Obstructive Sleep Apnea
Minimally Invasive Electrical Stimulation Of The Nerve Hypoglossal for the Treatment of Obstructive Sleep Apnea
Minimally invasive electrical stimulation of the nerve hypoglossal for the treatment of obstructive sleep apnea. To demonstrate the correct stimulation of the medial branches of the hypoglossal nerve and tongue protrusion using a…
- Trial name
- NCT05914948
- Testing
- Medtronic 8-contact Vectris subcompact or compact electrode.
- Where
- Colombia
- Volunteers
- 20 people
- Sponsor
- Capri Medical Limited
Obstructive Sleep Apnea
The Evaluation of a Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea (OSA) in NZ
This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the nasal pillows mask amongst Obstructive Sleep Apnea (OSA) participants.
- Trial name
- NCT02741635
- Testing
- New Nasal Pillows Mask
- Where
- New Zealand
- Volunteers
- 15 people
- Sponsor
- Fisher and Paykel Healthcare
Sleep Apnea, Obstructive
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery.
- Trial name
- PREDICTOR (NCT05428839)
- Testing
- Pharyngeal width measurement
- Where
- 10 sites in United States
- Volunteers
- 300 people
- Sponsor
- Inspire Medical Systems, Inc.
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
Obstructive Sleep Apnea
StimAire Sleep Study
The StimAire Model S is intended to treat Obstructive Sleep Apnea (OSA) by stimulating the hypoglossal nerve. The system includes a dedicated neurostimulator and a breathing sensor.
- Trial name
- NCT05374941
- Testing
- Injectable and wearable neurostimulator for the hypoglossal nerve
- Where
- Australia
- Volunteers
- 7 people
- Sponsor
- StimAire Australia Pty Ltd
Obstructive Sleep Apnea
Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study
Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an…
- Trial name
- NCT04718142
- Testing
- vNEP
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Somne, LLC
Obstructive Sleep Apnea
Clinical Evaluation of a Wearable Sleep Diagnosis Technology
The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.
- Trial name
- NCT03544086
- Where
- United Kingdom
- Volunteers
- 150 people
- Sponsor
- Acurable Ltd.
Syndrome of Obstructive Sleep Apnea and Hypopneas
Mandibular Advancement Devices Tali® in Patients With Syndrome of Obstructive Sleep Apnea and Hypopneas
The main objective is to evaluate middle term compliance (≥ 2 years) of the Mandibular Advancement Devices Tali® in patients with Syndrome of Obstructive Sleep Apnea and Hypopneas.
- Trial name
- NCT02878629
- Testing
- Mandibular Advancement Devices
- Where
- France
- Volunteers
- 254 people
- Sponsor
- ONIRIS