Clinical trials: Obstructive Sleep Apnea (OSA)
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 (OSA)
Data Collection Study to Review Novel Methods for Diagnosing Obstructive Sleep Apnea
This study will collect data on a range of signals such as facial scans, videos (including speaking, blinking and swallowing) and heart rate variability to assess whether any of these measures are useful for diagnosing…
- Trial name
- Ignite (NCT06930404)
- Testing
- facial scans, videos and heart rate variability measurements
- Where
- Australia
- Volunteers
- 800 people, healthy volunteers welcome
- 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 (OSA), Positional Obstructive Sleep Apnea
Effectiveness of Audio Cues to Achieve Positional Therapy in Patients With Positional Obstructive Sleep Apnea
Patients with obstructive sleep apnea (OSA) often experience more frequent and severe breathing disturbances when sleeping in the supine (back-sleeping) position compared with non-supine positions.
- Trial name
- NCT07714330
- Testing
- Investigational Positional Therapy Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SleepDev, Inc
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.
Apnea (Central and Obstructive)
MEntA Program Based on Motivational Interview to Improve Adherence to Treatment of Obstructive Sleep Apnea With Continuous Positive Airway Pressure (CPAP)
A randomized, controlled, single-centre trial design was performed. The interventions were standard of care vs MEntA Program based on motivational interview for adherence.
- Trial name
- MEntA Program (NCT07258264)
- Testing
- Motivational Interviewing (MI), Competency-based learning
- Where
- Spain
- Volunteers
- 100 people
- Sponsor
- Air Liquide Healthcare Spain
Obstructive Sleep Apnea of Adult
Clinical Trial of the Cryosa System for the Treatment of Obstructive Sleep Apnea
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
- ARCTIC-3 (NCT06008626)
- Testing
- Cryosa Procedure
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Cryosa, Inc.
Obesity, Overweight
AMAZE 4: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Obstructive Sleep Apnoea Treated With Positive Airway Pressure Lose Weight and Improve Sleep Apnoea
This study is being done to look at the efficacy and safety of NNC0487-0111 in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure.
- Conditions
- Obesity, Overweight, Obstructive Sleep Apnoea
- Trial name
- AMAZE 4 (NCT07571109)
- Testing
- NNC0487-0111
- Where
- 92 sites in United States, Australia and 8 more
- Volunteers
- 300 people
- Sponsor
- Novo Nordisk A/S
Apnea, Sleep
Radiofrequency Ablation for Multi-level Obstructive Sleep Apnea: A Single-arm, Multicenter Study
The United States is currently experiencing an increase in the incidence and prevalence of obstructive sleep apnea (OSA). With prevalence in middle-aged adults of 2 to 4% of the population, untreated OSA has been implicated in…
- Trial name
- NCT02349893
- Testing
- RFA treatment
- Where
- 6 sites in United States
- Volunteers
- 56 people
- Sponsor
- Olympus Surgical Technologies Europe
Obstructive Sleep Apnea
Post Market Clinical Follow up of ResMed Mask Systems
Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
- Trial name
- NCT05262439
- Testing
- New generation CPAP mask
- Where
- Australia
- Volunteers
- 500 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Adherence Risk Indicator Validation Study
While continuous positive airway pressure (CPAP) is the gold standard treatment of obstructive sleep apnea (OSA), this therapy is often discontinued or not used optimally.
- Trial name
- ARI (NCT02230085)
- Testing
- Administration of the questionnaire and monitoring of CPAP adherence
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Fisher and Paykel Healthcare
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
Obstructive Sleep Apnea
Comparison Study of the ICON™ CPAP Series With and Without SensAwake™
Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy.
- Trial name
- NCT01831258
- Testing
- SensAwake On, SensAwake Off
- Where
- 3 sites in United States
- Volunteers
- 70 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA
The goal of this randomised, double-blind phase II/III clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnoea who are intolerant, non-compliant, or naïve to positive airway…
- Trial name
- REPOSA (NCT06146101)
- Testing
- IHL-42X Low Dose, IHL-42X High Dose, IHL-42X (Optimal Dose)
- Where
- 20 sites in United States
- Volunteers
- 121 people
- Sponsor
- Incannex Healthcare Ltd
Obstructive Sleep Apnea
Workflow Validation of an In-home Auto-titrating Mandibular Positioner
The purpose of the study is to test the workflow of an auto-titrating mandibular positioner in its intended setting. Participants with obstructive sleep apnea will use the device to determine their eligibility for oral appliance…
- Trial name
- NCT02933112
- Testing
- Auto-titrating mandibular positioner test
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Zephyr Sleep Technologies
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 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
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.
Snoring, Obstructive Sleep Apnea
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.
- Trial name
- NCT03640793
- Testing
- Implantation
- Where
- Switzerland
- Volunteers
- 25 people
- Sponsor
- Medartis AG
Obstructive Sleep Apnea
Exploration of Current and New Technologies for Accuracy of Diagnosing OSA
Resmed is the manufacturer of medical devices which screen, diagnose, treat and monitor people with sleeping and respiratory disorders, such as obstructive sleep apnea (OSA).
- Trial name
- NCT07485582
- Testing
- Device A, Device B, Device C
- Where
- 5 sites in Australia
- Volunteers
- 90 people
- Sponsor
- ResMed