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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT04768543 Completed - Clinical trials for Obstructive Sleep Apnea

Stimulation Therapy for Apnea: Reporting Thoughts

START
Start date: March 2, 2020
Phase:
Study type: Observational

Upper airway stimulation (UAS) via unilateral implantation of a phasic hypoglossal nerve stimulation device is a safe and effective alternative treatment for patients with moderate to severe obstructive sleep apnea (OSA) who are unwilling or unable to adhere to positive airway pressure (PAP) therapy. Although adherence to UAS is higher than to PAP, there remain patients who are not using UAS consistently. The aim of this project is to explore critical factors in the use of UAS by OSA patients using qualitative research methods (personal interviews). The proposed study will provide crucial information about patients' concerns regarding UAS use and suggestions for how to support new UAS recipients.

NCT ID: NCT04760002 Completed - Clinical trials for Obstructive Sleep Apnea

DANish Patients With Atrial Fibrillation and Sleep Apnea Prevalence by Night Owl

DANAPNO
Start date: January 25, 2021
Phase:
Study type: Observational [Patient Registry]

A project of the feasibility of using NightOwl to detect the prevalence of obstructive sleep apnea (OSA) in patients with atrial fibrillation (AF). The long-term aim is to use the device to screen for OSA in a randomized clinical trial in AF patients undergoing ablation and/or a randomized trial of AF patients undergoing cardioversion.

NCT ID: NCT04759157 Completed - Clinical trials for Obstructive Sleep Apnea

We-PAP: A Couples-based Intervention for Sleep Apnea

We-PAP
Start date: March 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to develop, refine and evaluate the feasibility of a novel couples-based intervention to improve adherence for patients with obstructive sleep apnea (OSA).

NCT ID: NCT04753684 Completed - Clinical trials for Obstructive Sleep Apnea

Correlation Between Upper Airway Endoscopy and Physiological Traits of Obstructive Sleep Apnea

Start date: February 15, 2021
Phase:
Study type: Observational

OBJECTIVES To train and test a mathematical model to predict complete concentric collapse at the level of the palate (CCCp, primary) and other sites of upper airway collapse (secondary) during drug-induced sleep endoscopy (DISE) using the data captured during a diagnostic polysomnography (PSG). HYPOTHESIS The site, pattern and degree of upper airway collapse is associated with distinct flow features as captured during a baseline PSG. STUDY DESIGN Retrospective trial. STUDY POPULATION 200 patients with moderate to severe obstructive sleep apnea (OSA, AHI ≥ 15/h) who underwent both a DISE and a diagnostic PSG at the Antwerp University Hospital (UZA) between January 2018 and December 2020. OUTCOME MEASURES: Raw data as captured during a diagnostic PSG, including electroencephalography (EEG), flow, electrocardiography (ECG), electromyography (EMG), oxygen desaturation and breathing effort. SAMPLE SIZE / DATA ANALYSIS Data of 200 patients will be retrospectively included into this study protocol. Different machine learning techniques will be adopted to select features, train the model and test the model. TIME SCHEDULE January 30, 2021 - November 30, 2021

NCT ID: NCT04746105 Completed - Clinical trials for Patients With Mild Obstructive Sleep Apnea Hypopnea

A Clinical Pharmacology Study of TS-142 in Patients With Obstructive Sleep Apnea Hypopnea.

Start date: February 24, 2021
Phase: Phase 1
Study type: Interventional

A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.

NCT ID: NCT04744038 Completed - Clinical trials for Obstructive Sleep Apnea (OSA)

Evaluating the Efficacy of PAP Therapy for Treating OSA in the Home Environment

Start date: August 12, 2020
Phase: N/A
Study type: Interventional

This study will take between 4-6 months (with first patient first visit to last patient last visit expected to span 3-4 months across all study sites). Each participant will use the investigational PAP device with their own mask for a period of up to 7 nights and will complete a series of questionnaires upon completion. The study will evaluate the usability and efficacy of the investigational device in the intended use environment by the intended use population.

NCT ID: NCT04741022 Completed - Clinical trials for Coronary Artery Disease

Influence of Obstructive Sleep Apnea on the Severity of Coronary Artery Disease

Start date: February 14, 2017
Phase:
Study type: Observational [Patient Registry]

It is widely accepted that coronary artery disease (CAD) is related to a high mortality. It is predicted that an increase of approximately 21.3 million cardiovascular events and 7.7 million cardiovascular deaths over 2010 to 2030 in China.1 Male sex, diabetes mellitus, hypertension, hypercholesterolemia, obesity and smoking are all traditionally considered as risk factors for CAD. In recent decades, tremendous progress toward the prevention and treatment of traditional cardiovascular risk factors have helped decrease the morbidity and mortality from CAD, but the condition remains a major public health challenge worldwide. Looking into the other potential risk factors (OSA) for CAD, it may help to develop additional preventative strategies and further reduce the incidence and mortality of CAD.

NCT ID: NCT04726514 Completed - Clinical trials for Obstructive Sleep Apnea

SleepFlexTM Treatment of Obstructive Sleep Apnea

Start date: July 20, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA

NCT ID: NCT04718142 Completed - Clinical trials for Obstructive Sleep Apnea

Variable Negative External Pressure (vNEP) - An Alternative to Continuous Positive Airway Pressure (CPAP) for the Treatment of Obstructive Sleep Apnea (OSA): A Pilot Study

Start date: October 19, 2020
Phase: N/A
Study type: Interventional

Non-compliance rates estimated at 50% pose a major issue for CPAP therapy, the primary treatment for OSA. Negative external pressure, applied over the anterior neck under the mandible, has shown encouraging results as an alternative therapy. This study assessed a variety of sizes and shapes of collars and a range of pressures for variable negative external pressure (vNEP) treatment in subjects having moderate OSA to identify combinations that improve the efficacy and comfort of this emerging therapy. Observations made in this study may be used to plan a more definitive follow-on investigation.

NCT ID: NCT04713826 Completed - Clinical trials for Sleep Apnea, Obstructive

A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea

SPRAY-SMART
Start date: March 3, 2021
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat people with obstructive sleep apnea (OSA). In people with OSA, the upper airways can narrow or close repetitively while sleeping. These breathing interruptions lead to reduction of oxygen in the blood or short arousals from sleep. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how well it works. In this trial, the researchers want to learn more about how well BAY2586116 works in a small number of participants with OSA. The trial will include about 160 men and women who have OSA and are at least 18 years old. Women can only be included in this trial if they are not able to have children naturally. In this trial, the participants will take BAY2586116 and a placebo. A placebo looks like a treatment but does not have any medicine in it. All of the participants will take BAY2586116 through a nasal spray. They will also take the placebo as a nasal spray. This will be a crossover trial. This means all the participants will take both trial treatments one after the other, but in a different order. The participants will take each treatment once a day for 7 days. The researchers will use a measurement called the apnea-hypopnea-index (AHI) to measure the severity of the participants' OSA. The researchers will then compare the participants' AHI scores when they take BAY2586116 and when they take the placebo. During study, the participants will visit their trial site 5 times. At these visits the doctors will take blood samples, do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will also ask the participants questions about how they are feeling and if they have any medical problems. At 3 of the visits, the participants will stay at the trial site overnight. At these visits, the doctors will calculate the number of times the participants stop breathing per hour of sleep. After treatment, the participants will have a final visit 7 days later so the doctors can check their health.