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196 active trials for Obstructive Sleep Apnea

Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea

This trial will aim to test a new wearable device for the diagnosis of Sleep Apnoea.

Start: September 2019

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis. In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.

Start: October 2016

Inspire Home Study: Utilization of Home Monitoring During Therapy Optimization in Patients With an Inspire Upper Airway Stimulation System (Comparison of Home Sleep Testing vs. In-lab Polysomnography Testing)

Inspire intends to conduct this study to compare Apnea-Hypopnea Index (AHI), between the two randomization arms, at 6 months post-activation

Start: July 2020

Follow-up of Apneic Patients by Visio-consultation

Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .

Start: September 2020

Is the Daytime Sleepiness Based on Epworth Sleepiness Scale a Good Way to Assess Taiwanese With Suspected Obstructive Sleep Apnea.

This observational survey with retrospective follow-up is designed to study the daytime sleepiness based on Epworth Sleepiness Scale a good way or not to assess Taiwanese with suspected obstructive sleep apnea.

Start: January 2016

The Recovery in Stroke Using PAP Study

The proposed study is a randomized controlled trial among 180 patients with acute ischemic stroke and mod/severe OSA diagnosed by ambulatory PSG comparing PAP treatment with usual care concerning the primary outcome of functional recovery.

Start: September 2019

OSA as a Remote Ischemic Preconditioning in Vascular Surgery

Ischemia and reperfusion (I/R) injury during abdominal aortic aneurysm (AAA) repair is inevitable and may lead to postoperative multi-organ failure. Remote ischemic preconditioning (short periods of ischemia in anticipation of longer period of ischemia) may act protectively against ischemia. Studies of ischemic preconditioning in patients with AAA are conflicting. Obstructive sleep apnea (OSA) is a sleep disordered breathing syndrome which may have a protective effect against ischemia. The investigators hypothesize that I/R injury will be less pronounced in patients who have OSA and that the extent of I/R injury will inversely correlate with OSA severity. Accordingly, the aim of this study is to compare postoperative complications and markers of I/R in patients undergoing elective AAA repair who do and do not have OSA.

Start: November 2020

Impact of Sugammadex vs. Neostigmine Reversal on Post-Operative Recovery and Complications

Sugammadex or neostigmine are given at the end of the surgery to reverse neuro muscular blocking drugs. This study will evaluate whether reversal of NMBD with sugammadex is associated with faster recovery than neostigmine resulting in faster discharge from the operating room (OR) in obese patients with OSA undergoing bariatric surgery. Half of the patients in the study will receive sugammadex and the other half of the patients will receive neostigmine.

Start: January 2019

Recruitment Strategies Comparing Different Strategies in Sleep Apnea and Prediabetes

Recruitment strategies comparing different strategies.

Start: October 2019

Effects of Physical Activity on OSA Severity Based on the Level of Fluid Shift

Obstructive sleep apnea (OSA) is characterized by complete or partial upper-airway collapse during sleep associated with sleepiness. OSA causes severe impairments in quality of life (sleepiness, tiredness, concentration difficulties). Moreover, OSA has adverse consequences on the cardiovascular system by causing intermittent hypoxia, increased sympathetic nervous system activation and vascular endothelial dysfunction. Continuous Positive Airway Pressure (CPAP) and mandibular advanced devices (MAD) remain the two first-line therapies for OSA. However, not all patients are eligible for these treatments or are not able to follow for a lifelong therapy and therefore do not use it consistently. A recent meta-analysis has confirmed that regular physical activity reduces OSA by approximately 28% (Mendelson et al. 2018). However, an important inter-individual variability exists and no study to date has identified characteristics of patients who respond to these interventions. The aim of this Prospective study, single-site, non-randomized 4-week trial is to evaluate the impact of a 4-week physical activity intervention on the apnea-hypopnea index (AHI) in OSA patients based on their baseline fluid shift level. Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.

Start: October 2020

Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)

The primary objective of this study is to identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of OSAS with PAP in children with DS.

Start: August 2019

Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications

The purpose of this study is to: Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.

Start: January 2021

Magnetic Resonance Imaging in Obstructive Sleep Apnea

There is a fundamental gap in the investigators ability to design effective surgical treatment of obstructive sleep apnea (OSA) for the 30-40% of patients who cannot tolerate non-surgical treatment. OSA surgery outcomes vary widely, with the chances of a successful outcome ranging from 5% to 65% for individual or combination procedures. To predict - and thereby to improve - outcomes, the investigators must determine what predicts surgical success. This project will compare findings from two evaluations: drug-induced sleep endoscopy (DISE) and upper airway magnetic resonance imaging (MRI). DISE has demonstrated important benefits, but it has important limitations. Upper airway MRI is the most complete evaluation performed during wakefulness, making it conducive to broad application and less expensive than DISE, but there are no studies utilizing MRI as a surgical evaluation. The investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe OSA. In addition to history, physical examination, and polysomnogram (sleep study), all subjects will undergo DISE and MRI to characterize the pattern of obstruction. The investigators will examine the association between DISE and MRI, focusing on specific DISE findings that have been associated with surgical outcomes. The investigators multidisciplinary team has substantial expertise and experience in OSA investigation, DISE, and upper airway MRI.

Start: July 2014

Sleep Study-Guided Multidisciplinary Therapy for Patients Presenting With Acute Coronary Syndrome

The aim of this randomized, open-label clinical trial is to determine the impact of Sleep Study-Guided Multidisciplinary Therapy (SGMT, i.e. continuous positive airway pressure and behavioral therapy) for obstructive sleep apnea (OSA) in the sub-acute phase of acute coronary syndrome on cardiovascular outcomes. We hypothesize that SGMT will result in a lower (1) plasma NT-pro BNP, ST2 levels and hs-CRP, (2) 10-year risk of cardiovascular mortality based on the European SCORE algorithm, and (3) cardiovascular event rate, when compared with Standard Therapy. OSA is an emerging cardiac risk factor and prognostic marker. We have reported that OSA is a prevalent and independent predictor of adverse outcomes in patients with acute coronary syndrome. In this clinical trial, a continuation of my research and publication trajectory, 180 patients presenting with acute coronary syndrome will be randomly assigned to SGMT (n=90) or Standard Therapy (n=90) groups. Both groups will receive guideline-mandated treatment for acute coronary syndrome. Those assigned to SGMT will undergo a sleep study. Those found to have OSA will attend the SGMT clinic run by a multidisciplinary team. Advice on continuous positive airway pressure and behavioral therapy (weight loss, exercise, positional therapy, abstinence of alcohol and sleeping pills) will be given. The primary endpoint is plasma NT-pro BNP concentration at 6-month follow-up. The secondary endpoints are ST2, hs-CRP, 10-year risk of cardiovascular mortality based on the European SCORE algorithm which includes age, sex, smoking status, systolic blood pressure, and serum total cholesterol or total/HDL-cholesterol ratio. Adverse cardiovascular events at 3-year follow-up will be determined. In our aging population with an increasing prevalence of obesity, OSA will potentially become an increasingly important contributor to cardiovascular disease. Leveraging the collective expertise of a team of cardiologists and sleep physicians, our work will benefit society by advancing our understanding of the cardiovascular benefits of screening for and treating OSA.

Start: July 2016

The Pathogenesis of OSA in People Living With HIV

The purpose of this study is to help us understand how HIV and/or Anti-Retroviral Therapy (ART) may predispose individuals to Obstructive Sleep Apnea (OSA). The traditional risk factors for OSA are weight and age. However, people living with HIV on ART seem to have OSA even when they are thin and young. The study involves a detailed physiological sleep study and an MRI of the head and neck to understand the underlying cause of OSA in those with and without HIV.

Start: February 2017

Pulse Oximeter for Sleep Evaluation

The investigators will conduct this study to validate Belun Ring for sleep assessment. The investigators will compare Belun Ring data collection and overnight in-lab polysomnography (PSG) measures of SDB and sleep architecture in adults with OSA symptoms. The investigators propose to recruit a total of 40 participants with symptoms of obstructive sleep apnea. The investigators will i) validate the overall accuracy, sensitivity and specificity of Belun Ring to assess SDB and sleep architecture, using PSG analysis as a gold standard.

Start: July 2020

Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea

The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested: Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance. Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.

Start: September 2017

Evaluatation of Appscent Device Safety and Effectiveness for Relief of Obstructive Sleep Apnea (OSA) Syndrome in Adults.

Obstructive Sleep Apnea (OSA) syndrome is a disorder characterized by repetitive episodes of upper airway obstruction that occur during sleep. The standard treatment for apnea remains a device consisting of a pump and nasal mask that provide continuous positive airway pressure (CPAP). The major disadvantage of CPAP is the relatively low compliance. Appscent developed a non-contact effortless bedside solution based on the following: odors modify respiratory patterns during wake . Mildly trigeminal and pure olfactory odorants do not arouse or wake.

Start: October 2020

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Mild intermittent hypoxia (MIH) initiates sustained increases in chest wall and upper airway muscle activity in humans. This sustained increase is a form of respiratory plasticity known as long-term facilitation (LTF). Repeated daily exposure to mild IH that leads to the initiation of LTF of upper airway muscle activity could lead to increased stability of the upper airway. In line with PI's laboratory's mandate to develop innovative therapies to treat sleep apnea, this increased stability could ultimately reduce the continuous positive airway pressure (CPAP) required to treat obstructive sleep apnea (OSA) and improve compliance with this gold standard treatment. Improved compliance could ultimately serve to mitigate those comorbidities linked to sleep apnea. Moreover, in addition to improving CPAP compliance numerous studies indicate that mild IH has many direct beneficial effects on cardiovascular, neurocognitive and metabolic function. Thus, mild IH could serve as a multipronged therapeutic approach to treat sleep apnea. In accordance with this postulation, our proposal will determine if repeated daily exposure to mild IH serves as an adjunct therapy coupled with CPAP to mitigate associated co-morbidities via its direct effects on a variety of cardiovascular, metabolic and neurocognitive measures and indirectly by improving CPAP compliance. Modifications in autonomic (i.e. sympathetic nervous system activity) and cardiovascular (i.e. blood pressure) function will be the primary outcome measures coupled to secondary measures of metabolic and neurocognitive outcomes.

Start: November 2018

The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA

This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea.

Start: September 2020