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196 active trials for Obstructive Sleep Apnea

3D Printer Modified CPAP Mask for Obstructive Sleep Apnea

This is a prospective pilot to investigate the effect of 3D printer customized CPAP masks on the comfort of patients with obstructive sleep apnea.

Start: April 2018

Healthcare Renunciation in Respiratory Chronic Disease and Treatment Compliance (OBSERVE)

Health care renunciation is a factor that can alter patients' health status and increase the costs of its support. To date, there is no national data on the renunciation of care. This study will initially characterize the different forms of health care renunciation in patients with chronic respiratory diseases, treated with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) , and analyze it impact on treatment compliance and health processes. The follow-up of these patients during 5 years will define renunciation trajectories (transition from the state of "renouncing" to "non-renouncing" and vice versa) and their impact on treatment compliance. The investigators hypothesize that a patient becoming renounced on a given treatment also decreases his treatment compliance (CPAP or NIV ). The impact of the renunciation trajectory on the patient's follow-up in terms of hospitalizations and deaths will also be studied.

Start: June 2018

Measurement of Cerebral rSO2 Levels During Sleep in Children With Suspected Obstructive Sleep Apnea

The gold standard of obstructive sleep apnea (OSA) is (PSG)POLYSOMNOGRAPHY. During the examination, the patient is monitored by saturation, EEG and other measurements. Near infrared spectroscopy is an uprising technology allowing non invasive measurement of the frontal lobe oxygenation. It is painless and does not have side effects. We believe that brain saturation will be more accurate then peripheral pulse oximeter and will be better correlated with the clinical presentation of OSA.

Start: September 2019

Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia

Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. Our overarching hypothesis is that patients with OSA and hypoxia (H-OSA) have greater degrees of insulin resistance in both liver and adipose tissue when compared to those without hypoxia (NH-OSA) thus leading to increased risk for the development of diabetes in the former group.

Start: October 2018

NO Measurements in Screening for Asthma and OSA, in Patients With CRSwNP

Chronic rhinosinusitis with nasal polyps (CRSwNP) is a condition resulting in varying degrees of nasal congestion, nasal secretion, facial pain and reduced or absent sense of smell. In Denmark an estimated 200.000 patients suffer from this condition. It affects the quality of life in a degree equivalent to chronic cardiac and respiratory conditions. CRSwNP is known to be associated with inflammation in the nose and sinuses. In some patients the inflammation is also present in the lower airway resulting in shortness of breath, chest constriction, wheezing and coughing. It follows that asthma is often seen in patients with CRSwNP. Even though the association of asthma and CRSwNP is well known it is easy to overlook the asthma further reducing the quality of life. Previous studies have found that undiagnosed asthma is present in about a quarter of patients with CRSwNP. While many of the CRSwNP patients are treated in private ENT practice alone the lack of simple diagnostic tests giving a reliable measurement of airway inflammation is a challenge in diagnosing concurrent asthma. A recent study showed measuring of fractional exhaled nitrogen oxide (FeNO) in exhaled air to be a promising diagnostic test. The concentration of this gas in the exhaled air from the nose and mouth is related to the degree of airway inflammation and can therefore be used as a surrogate measurement in a safe and easy way. With this study the investigators want to measure the concentration of FeNO in patients with CRSwNP in private ENT practices. The aim is to explore if it can be used as a screening test for asthma. The study will also screen the patients for obstructive sleep apnea (OSA). Patients will be recruited from three private ENT practices in the Capital Region of Denmark. Patients with CRSwNP will be recruited from their appointments in the ENT clinics. They will be offered inclusion in the study, and if they give an informed consent, an exhaled NO test and a thorough ENT examination including a fiberoptic examination of the upper airway will be performed. They will also be asked to fill out questionnaires on the severity of symptoms from the nose and lungs, sleep quality and their health in general. Patients will also undergo a sleep study (Cardio-Respiratory Monitoring = CRM) and tests of lung function. With signs of respiratory or sinus disease they will be referred for further investigations and treatment.

Start: September 2019

Prognostic Impact of Sleep Apnea on Cardiovascular Morbidity and Mortality, in End Stage Renal Disease Patients

The purpose of this study is to prospectively evaluate the impact of sleep apnea on the cardiovascular morbidity and mortality of patients with end-stage renal disease.

Start: June 2012

Prolonged Overnight Oximetry in Obstructive Sleep Apnoea

This study is looking at the way in which patients with obstructive sleep apnoea (OSA) are diagnosed. The investigators current practice is to offer patients who are referred to the sleep centre with possible sleep apnoea a single night's oximetry recording. A decision is then made based on this screening test as to whether the patient has OSA, does not have OSA or requires a further investigation. There can be significant variation in the severity of OSA between nights. This study is designed to investigate if recording data from multiple nights will give any better indication on the presence and severity of obstructive sleep apnoea. Patients referred for overnight oximetry recordings that report excessive daytime sleepiness are eligible to enter the trial. On enrolment participants will all undergo a single night recording with the oximetry device currently in use by the recruiting sleep centre. In addition they will be asked to wear the prolonged recording oximeter (PRO) that allows for multiple nights data to be stored, and continue wearing this for a total of four nights. On returning both oximetry devices, this data will then be analysed and if it demonstrates evidence of OSA participants will return to the standard clinical pathway and be offered a trial of treatment with continuous positive airway pressure (CPAP) therapy. If no evidence of OSA is seen participants will also revert back to the standard clinical pathway, which may involve a further inpatient sleep investigation being arranged. The number of patients identified as having OSA based on the single first night recording will be compared to those identified as having OSA only after the additional nights recording. All participants will return to the current standard pathway of care on leaving the trial.

Start: March 2020

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.

Start: October 2017

Predicting Cardiometabolic Risk in Mild-to-Moderate Obstructive Sleep Apnea: Inflammation vs. Apnea/Hypopnea Index

The purpose of the study is to compare the relative contribution of systemic inflammation vs. Obstructive Sleep Apnea (OSA) severity (as measured by Apnea Hypopnea Index) in predicting cardiovascular and metabolic aberrations associated with mild-to-moderate obstructive sleep apnea.

Start: March 2017

Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea

The purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.

Start: March 2020

TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study

Primary aim of the TURKAPNE (The Turkish Sleep Apnea Database) study is to generate a cross-sectional nationwide database to define clinical and polysomnographic characteristics of the sleep apnea patients in Turkey. Associations of phenotypes of sleep apnea patients with metabolic and cardiovascular diseases as well as risk for traffic accidents will be explored as secondary aims. Impact of treatment of sleep apnea on metabolic and cardiovascular complications as well as compliance with positive airway pressure treatment will be further explored longitudinally.

Start: October 2017

The Multi-Ethnic Lifestyle Study

The study design is cross-sectional using a self-completion questionnaire in an English speaking multi-ethic population within Leicester and Leicestershire. The study will adopt a convenient and purposive sampling recruitment strategy across a variety of settings within Leicestershire to facilitate recruitment of a wide range of participants.

Start: December 2018

Obstructive Sleep Apnoea and Cardiac Arrhythmias

This study is a prevelance trial looking at how sleep apnoea affects the heart especially heart rhythms. Previous research shows that patients suffering from sleep apnoea are much more likely to get heart disease and abnormal heart rhythms (arrhythmias). These defects are sometimes missed by the traditional methods of monitoring i.e. 24-hour Holter monitor and ECGs. This means potentially dangerous arrhythmias may not be detected. Additionally, standard therapy for sleep apnoea does not significantly reduce the risk of heart disease. This study will recruit 200 participants over a period of 18 months. The research team will observe the heart rhythms of sleep apnoea patients by inserting an implantable loop recorder (ILR) in up to 100 participants. The other 100 patients will simply have standard care. This device will monitor the heart continuously for 3 years allowing us to detect abnormal heart rhythms and treat as necessary. Demonstrating the incidence of arrhythmia can lead onto a larger study which may change future sleep apnoea management improving their cardiovascular outcomes. Other markers of heart disease such as; blood tests, Magnetocardiography and Echocardiography will be performed on participants to shed more light on the mechanisms which link sleep apnoea and heart disease/arrhythmia.

Start: October 2019

Severe Obesity Outcome Network Cohort (SOON)

The main objective of the study is to identify the determinant of sleep characteristics of obese patients attempting a tertiary clinical center for obesity management, including bariatric surgery. More accurately the questions addressed are: What are the determinants of the sleep habits (sleep duration, chronotype) and of their evolution What are the determinants of sleep breathing disorders (sleep apnea, obesity hypoventilation syndrome) and of their evolution

Start: January 2014

Acetazolamide Add-On Therapy to OSA Surgery

Surgical procedures are routinely performed as an alternative to continuous positive airway pressure treatment in patients with obstructive sleep apnea (OSA). However, the response to surgery is often variable. Instability of the respiratory control during sleep (or high loop gain) has been associated with poor surgical results in previous research. Acetazolamide (AZM), a carbonic anhydrase inhibitor, has shown potential in reducing loop gain without affecting other physiological OSA traits. In this protocol the investigators will evaluate the clinical efficacy of AZM add-on therapy to surgical procedures in patients with OSA.

Start: January 2020

Role of Obstructive Sleep Apnea Syndrome in the Occurrence of Diabetic Retinopathy in Type 2 Diabetes.

Diabetic retinopathy (DR) is the most common visual complication of diabetes. Risk factors for developing DR are diabetes duration, glycemic control, and hypertension . The prevalence ranges from 17 to 61% according to the diabetes duration . Obstructive sleep apnea syndrome (OSAS) is very frequent in Type 2 Diabetes population, reaching a prevalence of 23-48% . Few is known about the exact role of OSAS in the development of DR. A recent study has shown that OSAS is an independent predictor for the progression to pre-/proliferative DR. The purpose of the present study is to assess if the presence of OSA in diabetic patients is a predictive factor for DR occurrence.

Start: October 2017

Measurement of Critical Closing Pressure (Pcrit) During Drug-Induced Sleep Endoscopy (DISE)

This study intends to test the feasibility of measurement of the critical closing pressure (Pcrit) during drug-induced sleep endoscopy (DISE) for use in future studies, which are aimed at finding an alternative method for patient selection and response prediction before implementation of non-CPAP therapies.Twenty patients diagnosed with OSA and eligible for non-CPAP treatments are going to be included into this study and undergo these measurements. Drug-induced sleep endoscopy (DISE) is part of the standard clinical care for OSA patients that are eligible for non-CPAP therapies. We aim to expand this procedure with measurement of Pcrit, oesophageal pressure, airflow, EEG, EOG, respiratory effort, SpO2 and chin EMG during this study.

Start: January 2020

The Effect of CPAP Treatment on Cognitive Functions, Anxiety, and Affective Symptoms

Long term, prospective study of continuous positive airway pressure treatment influence on cognitive functions in patients with obstructive sleep apnea syndrome.

Start: February 2019

Effect of CPAP Treatment in Cognition in Adults With DS and OSA

Adults with Down syndrome (DS) have a high prevalence of obstructive sleep apnea (OSA), which may worsen cognitive performance. In general population, continuous positive airway pressure (CPAP), the gold Standard treatment for OSA, partially reverses cognitive impairment secondary to OSA. CPAP treatment, however, is not regularly proposed in adults with DS and OSA. It is usually presumed both by caregivers and physicians, that DS patients will not tolerate or adapt to the treatment, and that they would not benefit much more from CPAP treatment. Therefore, data about the feasibility and impact of CPAP treatment on cognitive function in this population is lacking. The main objective of this study is to investigate cognitive performance in adults with DS and OSA, the corresponding functional brain changes and their reversibility with CPAP treatment.

Start: December 2019

Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients

With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation after successful catheter ablation procedure among patients with atrial fibrillation and obstructive sleep apnea. The results from this study will help us refine the design for a future larger study, and will ultimately improve care of patients with obstructive sleep apnea and atrial fibrillation.

Start: January 2019