Clinical trials: Obstructive Apnea
Obstructive Sleep Apnea, OSA
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation
Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are…
- Conditions
- Obstructive Sleep Apnea, OSA, Apnea, Apnea, Obstructive
- Trial name
- OSPREY (NCT04950894)
- Testing
- Hypoglossal Nerve Stimulation
- Where
- 19 sites in United States
- Volunteers
- 107 people
- Sponsor
- LivaNova
Snoring, Obstructive Sleep Apnea
Efficacy, Safety and Acceptability of Nastent™ in Snoring and Obstructive Sleep Apnea
This study evaluates the efficacy, the tolerance and the acceptability/compliance of the nasal airway stent, Nastent, for the treatment of mild to moderate OSA and snoring in European adult patients without cardiovascular and/or…
- Trial name
- NCT03510403
- Testing
- nastent™
- Where
- 6 sites in France
- Volunteers
- 32 people
- Sponsor
- Seven Dreamers Europe SAS
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.
Obstructive Sleep Apnea (OSA)
Inspire UAS High Apnea Hypopnea Index (AHI)/High Body Mass Index (BMI) Post-Approval Study
The purpose of this observational clinical study is to provide evaluation of long-term safety and effectiveness in a newly expanded patient population including patients with a higher AHI and a higher BMI.
- Trial name
- AHIBMI PAS (NCT07113288)
- Testing
- Inspire® UAS System
- Where
- 5 sites in United States
- Volunteers
- 70 people
- Sponsor
- Inspire Medical Systems, Inc.
Sleep Apnea, Obstructive, Excessive Daytime Sleepiness
A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Solriamfetol in the Treatment of Excessive Daytime Sleepiness (EDS) in Patients with Obstructive Sleep Apnea (OSA)
The purpose of this study is to evaluate the efficacy and safety of 12-week solriamfetol administration in the treatment of EDS in patients with OSA from China, using a randomized, double-blind, placebo-controlled, multi-center…
- Trial name
- NCT06103825
- Testing
- Solriamfetol
- Where
- 26 sites in China
- Volunteers
- 204 people
- Sponsor
- Ignis Therapeutics (Suzhou) Limited
Sleep Apnea, Asthma
Sleepiz One+ vs. Capnography and Electrocardiography
Respiratory Rate (RR) and heart rate (HR) are vital signs crucial for assessing a patient's overall health, providing insights into various conditions and stressors.
- Conditions
- Sleep Apnea, Asthma, COPD, Hypertension
- Trial name
- NCT06569940
- Testing
- Sleepiz One+
- Where
- Switzerland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Sleepiz AG
Obstructive Sleep Apnea
PAP-NAP Device Clinical Study
This exploratory pilot study will evaluate the usability and short-term tolerability of a novel positive airway pressure (PAP) device in adults during a supervised daytime nap session in a simulated sleep environment.
- Trial name
- NCT07785310
- Testing
- APL Device
- Volunteers
- 10 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
SLEEP ON Your SIDE (SOS) Study
Comparison of the NightBalance Sleep Position Trainer (SPT) to Positive Airway Pressure (PAP) for the Treatment of Positional Obstructive Sleep Apnea (POSA).
- Trial name
- SOS (NCT04211350)
- Testing
- NightBalance Sleep Position Trainer (SPT), Automatic Positive Airway Pressure (APAP)
- Where
- 18 sites in France, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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 Not 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 not receiving positive airway pressure (PAP)…
- Trial name
- NCT07787260
- Testing
- HDM1005
- Where
- China
- Volunteers
- 200 people
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Obstructive Sleep Apnea
Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask
The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure…
- Trial name
- NCT05818540
- Testing
- Eclipse novel CPAP mask, ResMed P-10 mask
- Where
- United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Bleep, LLC
Obstructive Sleep Apnea of Adult
BiLAteral Hypoglossal Nerve Stimulation for Treatment of Obstructive Sleep Apnoea (BLAST OSA)
The study is designed as a prospective, open-label, multicentre, non-randomized, single arm treatment study to assess the safety, performance and initial efficacy trends of the GenioTM System in patients with Obstructive Sleep…
- Trial name
- NCT03048604
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 3 sites in Australia, France and 1 more
- Volunteers
- 27 people
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)
The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.
- Trial name
- SEED (NCT05101122)
- Testing
- Dosing 1: Atomoxetine, AD313
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Apnimed
Sleep Apnea, Obstructive, Obstructive Sleep Apnea Syndrome
Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk.
- Trial name
- TELESAS (NCT01226641)
- Testing
- Telemedicine, Standard care
- Where
- 14 sites in France
- Volunteers
- 107 people
- Sponsor
- Initiative Pour la Sante
Obstructive Sleep Apnea
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.
- Trial name
- NCT04063436
- Testing
- New nasal pillows mask with PAP therapy
- Where
- United States
- 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
Obstructive Sleep Apnea, Sleep Apnea Syndromes
Real-World Performance and Safety of Apneal Dx for Sleep Apnea Screening
Sleep apnea-hypopnea syndrome (SAHS) is a frequent and largely under-diagnosed sleep-related breathing disorder. Adult prevalence is estimated between 9% and 38%. Untreated SAHS increases cardiometabolic and neurocognitive risk.
- Conditions
- Obstructive Sleep Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- Trial name
- APNEAL-PMCF (NCT07809633)
- Where
- France
- Volunteers
- 400 people
- Sponsor
- Mitral
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)
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea (ARCTIC_AUS)
This is a prospective, multicenter, non-randomized single-arm safety and performance study to collect data to evaluate the safety of the Cryosa procedure to treat obstructive sleep apnea (OSA) in patients with moderate to severe…
- Trial name
- NCT07021833
- Testing
- Cryosa Procedure
- Sponsor
- Cryosa, Inc.
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 Syndrome
Narval CC Mandibular Repositioning Device in the Second-line Treatment of Severe Obstructive Sleep Apnea Hypopnea (OSAH)
The purpose of this study is to evaluate the long-term efficacy, tolerance and compliance of ORM Narval Mandibular Repositioning Device (MRD) as a second-line treatment for patients with severe Obstructive Sleep Apnea Hypopnea…
- Trial name
- ORCADES (NCT01326143)
- Testing
- ORM Narval MRD
- Where
- 26 sites in France
- Volunteers
- 360 people
- Sponsor
- ResMed