Clinical trials: Apnea
Obstructive Sleep Apnea
BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse
The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5…
- Trial name
- BETTER SLEEP (NCT03763682)
- Testing
- Genio(TM) bilateral hypoglossal nerve stimulation system
- Where
- 4 sites in Australia
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Nyxoah S.A.
Obstructive Sleep Apnea
Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)
Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data
- Trial name
- NCT02590159
- Testing
- BONGO NASAL EPAP
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- InnoMed Healthscience Inc.
Obstructive Sleep Apnea
Investigation of a Novel Positive Pressure Therapy to Rescue Patients Failing to Tolerate CPAP During an Initial Encounter
The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the CPAP group after 90 days of treatment during the…
- Trial name
- BIPAP (NCT00635206)
- Testing
- BiPap auto with Fi Flex, Standard CPAP
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Clayton Sleep Insititute
Sleep Disorders
Evaluation of WP200 With the Unified Probe (WP200U)
The prevalence of OSAS is estimated at 2% and 4% for adult women and men respectively, most of whom are undiagnosed and untreated.
- Trial name
- NCT01929447
- Where
- Israel
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Itamar-Medical, Israel
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
Sleep Apnea, Obstructive
Titration Pressures in Sleep Apnea Patients Using ThermoSmart® Versus Conventional Humidification
Patients who have Obstructive Sleep Apnea (OSA) may have different Continuous Positive Airway Pressure (CPAP)when titrated with different levels of humidification.
- Trial name
- NCT00681083
- Testing
- Heated breathing tube (CPAP with ThermoSmart), Non heated breathing tube (CPAP with conventional humidification)
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- Fisher and Paykel Healthcare
Obstructive Sleep Apnea
Severe Label Expansion for EVO Products Trial
Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus…
- Trial name
- SLEEP (NCT07090395)
- Testing
- EVO Sleep and Snore Device
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- ProSomnus 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
Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea
This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.
- Trial name
- NCT04645524
- Testing
- AD182, AD504, Polysomnography
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Apnimed
Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)
The objective of the study is to determine the safety and preliminary 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
- NCT01532180
- Testing
- aura6000 System
- Where
- Belgium
- Volunteers
- 14 people
- Sponsor
- ImThera Medical, Inc.
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
Sleep Apnea Syndromes
Amara View Benchmark Study
This randomized crossover, benchmark clinical trial aims to compare the Philips Amara View and ResMed AirFit F40 minimal contact full face masks on patient preference of mask attributes and usage parameters.
- Trial name
- NCT06535932
- Testing
- Amara View Minimal Contact Full Face Mask, F40 Minimal Contact Full Face Mask
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Bradycardia
Registry of Sleep Apnea Monitoring and Atrial Fibrillation in Pacemaker Patients (RESPIRE)
The purpose of the study is to evaluate at 12 Months follow-up the association between Atrial Fibrillation (AF) and Sleep Apnea (SA) severity based on data measured and stored in REPLY 200 DR pacemaker.
- Trial name
- NCT01922726
- Where
- Spain
- Volunteers
- 1,257 people
- Sponsor
- MicroPort CRM
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
AirSense 10 AHI Validation Study
The AirSense 10 platform is able to detect respiratory events at night and report these data via telemonitoring. The accuracy of the AirSense 10 will be compared with scoring with polysomnography (PSG).
- Trial name
- NCT03043703
- Testing
- AirSense 10 AutoSet for Her
- Where
- 2 sites in Germany
- Sponsor
- ResMed