Clinical trials: Apnea, Obstructive
Obstructive Sleep Apnea (OSA)
Feasibility Study of the ReVENT Sleep Apnea System
This is a prospective, multi-center, single arm, feasibility study to evaluate the safety and effectiveness of the ReVENT Sleep Apnea System for the treatment of Obstructive Sleep Apnea.
- Trial name
- REV-001 (NCT02501304)
- Testing
- ReVENT Sleep Apnea System
- Volunteers
- 40 people
- Sponsor
- Revent Medical International B.V.
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.
Sleep Apnea Syndromes
Validation of Withings Sleep for the Detection of Sleep Apnea Syndrome
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general population. It aggravates morbidity and cardio-metabolic mortality and is responsible for accidents related to vigilance disorders.
- Trial name
- VPASS (NCT04234828)
- Where
- 2 sites in Belgium, France
- Volunteers
- 200 people
- Sponsor
- Withings
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
Sleep, Insomnia
Actigraphy, Wearable EEG Band and Smartphone for Sleep Staging
This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation.
- Conditions
- Sleep, Insomnia, Sleep Apnea Syndrome, Obstructive
- Trial name
- NCT04943562
- Testing
- ACT+EEG
- Where
- 2 sites in Brazil
- Volunteers
- 96 people
- Sponsor
- SleepUp Tecnologia em Saúde Ltda
Sleep Apnea, Obstructive, Sleep Apnea, Central
DreamKit Respiratory Effort Signal Validation
This study has been developed in order to demonstrate the validity of the DreamKit respiratory effort signal.
- Trial name
- NCT04926077
- Testing
- DreamKit
- Where
- United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
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.
COPD, Hypertension
Sleepiz One+ Versus Capnography and Electrocardiography
EtCO2, or exhaled carbon dioxide, is a non-invasive and commonly used measure for respiratory rate and function. It can be easily monitored using a device called a capnograph, which consists of a sensor that is placed near the…
- Conditions
- COPD, Hypertension, Sleep Apnea, Asthma
- Trial name
- SPZCAP (NCT05712226)
- Testing
- Sleepiz One+
- Where
- Switzerland
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Sleepiz AG
Obesity Hypoventilation Syndrome
AVAPS-AE Efficacy Study
The purpose of this study is to evaluate the feasibility of using of the Average Volume Assured Pressure Support (AVAPS-AE) mode versus Continuous Positive Airway Pressure (CPAP) and bilevel pressure support ventilation (PSV)…
- Trial name
- NCT01368614
- Testing
- AVAPS-AE Mode of Therapy, Respironics OnmiLab BiPAP S mode, Respironics OmniLab Advanced CPAP mode
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Philips Respironics
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