Clinical trials: OSAS
Obstructive Sleep Apnea
Comparison of Auto-Adjusting Positive Airway Pressure Devices
Little is understood about how different auto-adjusting PAP devices operate. The purpose of this evaluation is to compare two devices in a randomised two night PSG trial.
- Trial name
- NCT02357706
- Testing
- APAP A (ResMed AirSense AutoSet), APAP B (Apex iCH Auto)
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Safety and Performance Study of the Nyxoah SAT System for Treating OSA
A prospective open-label, single treatment study to assess the safety and the performance of the Nyxoah SAT system for the treatment of Obstructive Sleep Apnea
- Trial name
- NCT02312479
- Testing
- Nyxoah SAT system
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 6 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
Usability Evaluation of Menai CPAP Masks
The primary objective of this study is to evaluate the subjective performance of the Menai mask systems (full face, nasal, and pillows variants), compared against Comparison mask systems.
- Trial name
- NCT02364375
- Testing
- Menai mask (full face), Menai Standard mask (full face), Menai mask (nasal)
- Where
- Australia
- Volunteers
- 30 people
- Sponsor
- ResMed
Obstructive Sleep Apnea, Central Sleep Apnea
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects.
- Conditions
- Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration
- Trial name
- NCT02034175
- Testing
- SomnaPatch, Polysomnography
- Where
- 3 sites in United States
- Volunteers
- 190 people
- Sponsor
- Somnarus Inc
Sleep Apnea, Sleep Apnea, Obstructive
Evaluation of the Effects of Hypoglossal Nerve Stimulation in Humans With Obstructive Sleep Apnea
This proof-of-concept study is being performed to evaluate whether the hypoglossal nerve can be stimulated using a small series of electrodes placed surgically via a percutaneous approach.
- Conditions
- Sleep Apnea, Sleep Apnea, Obstructive, Sleep Disorder, Sleep Apnea Syndromes
- Trial name
- NCT06283017
- Testing
- Hypoglossal nerve stimulation
- Where
- Australia
- Volunteers
- 14 people
- Sponsor
- Invicta Medical Inc.
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Targeted Hypoglossal Neurostimulation Study #2
The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).
- Conditions
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory
- Trial name
- THN2 (NCT01796925)
- Testing
- aura6000 THN System
- Where
- 9 sites in United States, Belgium and 3 more
- Volunteers
- 57 people
- Sponsor
- ImThera Medical, Inc.
Obstructive Sleep Apnea
Improving the Efficiency of the Digital Sleep Workflow Using MATRx Plus
Sleep apnea (OSA) is a condition in which the air passage in the throat closes or partly closes during sleep and repeatedly interrupts breathing.
- Trial name
- NCT03579225
- Testing
- MATRx plus test
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Zephyr Sleep Technologies
Obstructive Sleep Apnea
Use of Blood Biomarkers and Biomarker Index to Aid in the Diagnosis of Obstructive Sleep Apnea (OSA)
This multicenter prospective trial will evaluate the association between obstructive sleep apnea (OSA) and blood biomarkers in a representative population of consecutively enrolled symptomatic patients with a clinical suspicion…
- Trial name
- NCT03122483
- Testing
- blood biomarker
- Where
- 3 sites in United States
- Volunteers
- 250 people
- Sponsor
- Beckman Coulter, Inc.
Obstructive Sleep Apnea
Developement of TipTraQ Home Sleep Test
The clinical study aims to develop and fine-tune the TipTraQ system, created by PranaQ, for home sleep apnea screening. The system comprises a wearable device and a cloud-based AI for estimating Total Sleep Time (TST) and…
- Trial name
- NCT06474351
- Where
- Taiwan
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- PranaQ Pte. Ltd.
Obstructive Sleep Apnea
Pediatric Post-Approval Registry
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe…
- Trial name
- NCT04457154
- Testing
- Inspire Upper Airway Stimulation System
- Where
- 8 sites in United States
- Volunteers
- 60 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Apnea
A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea
The main aim of the study is to check the side effects from overnight treatment with danavorexton and assess the tolerability of varying doses of danavorexton administered intravenously.
- Trial name
- NCT05180890
- Testing
- Danavorexton
- Where
- Australia
- Volunteers
- 13 people
- Sponsor
- Takeda
Sleep Apnea, Obstructive, Chronic Obstructive Pulmonary Disease
SNORE (Smartphone Analyses of Nocturnal Obstruction by Respiratory Evaluation) SOUNDS
This is a prospective multipart clinical performance study to compare the ability of the SnoreSounds algorithm with polysomnography (PSG) and a type III Home Sleep Testing (HST) device to identify patients with obstructive sleep…
- Trial name
- SNORESOUNDS (NCT03288376)
- Where
- 3 sites in United States
- Volunteers
- 272 people, healthy volunteers welcome
- Sponsor
- Incyphae, Inc.
Obstructive Sleep Apnea
Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM)
A multicenter study to assess the safety and effectiveness of the Genio dual-sided hypoglossal nerve stimulation system for the treatment of obstructive sleep apnea in adults subjects.
- Trial name
- DREAM (NCT03868618)
- Testing
- Genio™ system
- Where
- 21 sites in United States, Australia and 2 more
- Volunteers
- 115 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
An Investigation to Test the Efficacy of the High Flow (HF) Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea (OSA)
Phase One: High Flow (HF) CPAP (HF-CPAP) Titration: Participants will attend the sleep lab to undergo a comprehensive split-night respiratory PSG.
- Trial name
- NCT01025440
- Testing
- Continuous Positive Airway Pressure
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in OSA"
This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.
- Trial name
- OSA (NCT02348606)
- Testing
- JZP-110
- Where
- 59 sites in United States, Canada and 3 more
- Volunteers
- 476 people
- Sponsor
- Jazz Pharmaceuticals
Obstructive Sleep Apnea
Validation of Safety and Efficacy for Night Shift Therapy
The purpose of this study is to assess the accuracy of Night Shift in the detection of supine sleep and efficacy of vibro-tactile feedback in restricting supine sleep.
- Trial name
- NCT02032706
- Testing
- Deliver therapy when the supine position is detected
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Advanced Brain Monitoring, Inc.
Obstructive Sleep Apnea (OSA) and Obesity
A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of HDM1005 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Receiving Positive Airway Pressure (PAP) Therapy
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy and safety of the HDM1005 in patients with obstructive sleep apnea (OSA) and obesity receiving positive airway pressure (PAP)…
- Trial name
- NCT07794397
- Testing
- HDM1005
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea
Extension Study of Original Protocol AERO C009 for Obstructive Sleep Apnea-hypopnea
The purpose of this study is to evaluate the long-term durability of the treatment and safety of the Provent device for those individuals who were enrolled in the C009 study, were diagnosed with obstructive sleep apnea-hypopnea…
- Conditions
- Obstructive Sleep Apnea Hypopnea, Obstructive Sleep Apnea, OSAH
- Trial name
- AERO C009E (NCT00849043)
- Where
- 13 sites in United States
- Volunteers
- 65 people
- Sponsor
- Ventus Medical, Inc.
Obstructive Sleep Apnea
Field Usability Study of Eclipse Mask
The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd…
- Trial name
- NCT05559047
- Testing
- Eclipse mask
- Where
- 3 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea
A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults
The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.
- Trial name
- EliSA (NCT04031040)
- Testing
- Genio® system therapy
- Where
- 19 sites in Belgium, France and 3 more
- Volunteers
- 110 people
- Sponsor
- Nyxoah S.A.