Clinical Trials

The purpose of this study is to demonstrate feasibility of obtaining at home remote pre-operative testing for obstructive sleep apnea prior to elective non-cardiac surgery. Additionally, to determine if obstructive sleep apnea can be screened for during a remote preoperative evaluation.

The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

The purpose of this study is to advance the understanding of obstructive sleep apnea as it relates to different ethnic origins as well as sex differences. The investigators will compare Somali patients with known obstructive sleep apnea (OSA) to individuals without OSA, and to individuals of other ethnic/racial origins to determine the risk factors (genetic and/or physiologic) associated with developing cardiovascular diseases. This will help the investigators to understand the unique sleep pathology of individuals of African descent.

 The aggregate of microorganisms inhabiting the human gastrointestinal tract is dynamic in nature. They change their composition secondary to various physiological and pathological insults including an intermittent hypoxic state in Obstructive sleep apnea. The overall hypothesis of this study is that the human gut microbial species diversity, its relative composition, and the substance produced by them in participants with obstructive sleep apnea are subject to change following continuous positive airway pressure therapy.

The purpose of this study is to create a registry in order to collect Inspire therapy clinical evidence in the clinical practice setting, collect additional information on the effectiveness, use and safety in the commercial setting, and 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 ...

The purpose of this study is to test a new device for the treatment of obstructive sleep apnea that delivers an auditory tone to affect neuromodulation while minimizing sleep disturbance.

Studies show that sleep apnea increases the risk of cardiovascular disease and is associated with obesity. However, it is unclear how sleep apnea affects fat tissue. Studies have shown that fat tissue is likely involved in developing cardiovascular disease. The purpose of this study is to see how sleep apnea changes fat tissue.

The purpose of this study is to eEvaluate an under-mattress sleep monitor compared to a peripheral arterial tonometry home sleep apnea test device in the diagnosis of obstructive sleep apnea.

The purpose of this study is to we aim to examine the base rates, types, and severity of sleep apnea and oxygenation status during sleep in patients admitted to the Pain Rehabilitation Center (PRC) on opioid medication.

The purpose of this study is to demonstrate the feasibility of collecting KING Devick Test (KDT) data and confirm the relationship/association of utilizing this brain function test in the evaluation of obstructive sleep apnea (OSA) suspect patients.

The purpose of this study is to verify that a relatively inexpensive, readily available activity monitor can be used in sleep research.  Specifically, the interest is on children and adolescents as they will be the focus of future research.

The purpose of this study is to test the usefullness and initial effectiveness of an mHealth smartphone app to increase use of positive airway pressure (PAP) therapy in obstructive sleep apnea (OSA) patients treated at the Mayo Clinic Arizona Center for Sleep Medicine.

The purpose of this study is to determine if use of an educational video simulating common CPAP-related problems will increase compliance among new CPAP users.

The purpose of this study is to:

1. Evaluate if there are detrimental effects of restarting CPAP therapy on POD #0-1 in patients undergoing ESS compared to normal controls undergoing ESS without OSA.

2. Determine if there a difference in perception of pain and post-operative analgesia requirement in OSA patients restarting CPAP on POD #0-1 compared to non-OSA patients.

3. Determine if there are predictive factors for OSA patients undergoing ESS who require an overnight hospitalization after surgery.

4. Validate the nocturnal Rhinoconjuctivitis Quality ...

Sleep apnea is the most common form of sleep disordered breathing and patients with sleep apnea exhibit persistent activation of the sympathetic nervous system.  Sympathoexcitation is also the final common pathway for complications in conditions like obesity, hypertension, sleep apnea, and heart failure and plays a significant role in predicting negative clinical outcomes. However, the mechanisms of sympathoexcitation with sleep apnea are poorly understood and thus make effective therapeutic approaches difficult to develop. Intermittent hypoxia (IH) has been implicated in animal models as the primary stimulus for evoking increases in sympathetic activity with recurrent apneas. The overall goal of this application ...

This study is aimed at examining the alterations in adipose tissue in obstructive sleep apnea (OSA) patients in response to treatment with atorvastatin in continuation with standard treatment with continuous positive airway pressure (CPAP).

The purpose of this study is to evaluate whether use of the app to recommend positive airway pressure (PAP) masks reduces patient-initiated request for mask changes during the first 90 days of PAP use., and to evaluate whether use of the app results in improved patient satisfaction with PAP experience during the first 90 days of PAP use.

The primary purpose of this study is to analyze maxillary transverse dimensions in children who have completed polysomnography (PSG), using McNamara’s Criteria and Andrew’s Six Elements.

This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

The purpose of this study is to determine the prevalence of Obstructive Sleep Apnea (OSA) in HFpEF, and its clinical and hemodynamic correlates, and to determine the impact of intervention with CPAP therapy on exercise capacity and quality of life in HFpEF patients with OSA.

We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.

The purpose of this study is to compare respiratory volume monitor (RVM) assessments of apnea and Low MV to nursing assessments of respiratory depressive events in patients recovering from general anesthesia during Phase I recovery.

The purpose of this study is to evaluate the use of a smartphone app for stroke patients with obstructive sleep apnea in order to better use their positive airway pressure (PAP) therapy.

The purpose of this study is to elicit detailed information from patients diagnosed with a sleep-related breathing disorder with severe obesity and sleep medicine providers regarding attitudes toward and acceptance of a multicomponent weight loss intervention based in health coaching. We anticipate that gaining a deeper understanding of attitudes toward weight loss in this population will provide insight into what may be feasible and acceptable aspects of a weight loss intervention. This information will then help guide the development of a multicomponent weight loss intervention based in health coaching and aimed at decreasing disease burden, increasing PAP adherence, and improving ...

Obstructive sleep apnea (OSA) is associated with endothelial dysfunction and the development of cardiovascular disease. It is unclear how OSA results in endothelial dysfunction, but given the association between OSA and obesity, adipose-derived hormones (adipokines) are likely to be involved. Leptin, an adipokine upregulated in patients with OSA, has been shown to be associated with deleterious effects on vascular function resulting in impaired endothelial function. This proposal is directed at investigating the molecular mechanisms of endothelial dysfunction in OSA patients. We hypothesize that endothelial dysfunction associated with OSA is a result of molecular alterations within endothelial cells. As a part ...

This is a Phase 3 study to assess the long-term safety and maintenance of efficacy of JZP-110 in subjects who have completed Study 14-002, 14-003, 14-004, 15-004, 15-005, ADX-N05 201, or ADX-N05 202.

The purpose of this study is to determine prevalence of sleep apnea in patients with hypertrophic cardiomyopathy and assess cardiovascular risk markers.

The purpose of this study is to retrospectively review the charts of 200 patients for whom overnight oximetry data, pulmonary function tests, as well as echocardiographic data have been obtained as part of routine clinical assessment. In so doing, the hope is to assess the risk of sleep disorder breathing, as evidenced by the oxygen desaturation index (ODI) on overnight oximetry assessment.

The purpose of this study is to compare prevalence of sleep apnea and sleep disturbance in post-COVID-19 infected patients who had been symptomatic to COVID negative participants as controls. A sleep testing device will assess for sleep disordered breathing and the results will be aggregated to compare if a significant increase (any difference) in the prevalence of sleep disordered breathing diagnosis between the two groups. Sleep questionnares data will be obtained. A second part of this study will involve using a Fitbit consumer wearable device to obtain sleep and activity data on participants for 2 months in duration. 

The purpose of this study is to evaluate plasma biomarkers of vascular function and inflammation in patients with newly-diagnosed Obstructive Sleep Apnea (OSA) and pre-existing imaging evidence of Cerebral Small Vessel Disease (CSVD).

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

The purpose of this study is to determine prevalence of sleep apnea in patients with hypertrophic cardiomyopathy and the risk of atrial and ventricular arrhythmias.

The purpose of this study is to determine the incidence of atrial and ventricular arrhythmias in patients with hypertrophic cardiomyopathy, with and without sleep apnea.

A variety of liver insults lead to pathological changes in liver architecture that culminate in cirrhosis. While invasive liver biopsy was required to detect cirrhosis, the development of magnetic resonance elastography (MRE) has revolutionized our ability to detect liver fibrosis through non-invasive means that involve measurement of liver stiffness. However, a number of pathological findings occur in liver in response to various insults that precede cirrhosis and are clinically important to identify such as steatosis associated with NASH, inflammation associated with viral hepatitis, and congestion associated with cardiac hepatopathy. Detection of such entities provides essential diagnostic, prognostic, and treatment information ...

The purpose of this study is to identify the association between untreated OSA and chronic insomnia and their association with cognitive decline, increased Alzheimer's Disease (AD) and vascular pathology.

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep and is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure ...