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Research & Clinical Trials

Clinical Trial of Phrenic Nerve Stimulation in Central Sleep Apnea

(Respicardia industry funded trial)

The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by phrenic nerve stimulation in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive phrenic nerve stimulation systems. The primary effectiveness objective of the trial is to demonstrate that the Treatment group achieves an AHI reduction from baseline to 6 months post therapy initiation that is greater than the Control group. The primary effectiveness endpoint will be evaluated by comparing the proportions of subjects in the two study groups that meet the following success criterion: Subject success on the primary AHI endpoint is defined as a subject achieving a 50% or greater reduction in AHI from baseline to 6 months post-therapy initiation visit.

This study is starting recruitment. If you would like more information on this study please contact Joan Aylor, Research Coordinator, at 216.445.1698.

Elucidation of the Risk of Sleep Apnea in Atrial Fibrillation

(NHLBI 1 R01 HL 109493- 01, 2011-2016, PI: R Mehra): Relationships of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF) will be investigated. Data is collected in order to: clarify the extent that respiratory event frequency, apnea subtype (obstructive versus central), and hypoxia are associated with PAF independent of cardiac structural abnormalities (i.e. systolic dysfunction and increased left atrial volume); explore the extent to which cardiac morphology, pathways of inflammation, oxidative stress and autonomic dysfunction mediate the SDB-PAF relationship and identify whether temporal patterns of AF paroxysms differ in patients with SDB. We will also examine the extent of improvement in AF burden with sleep apnea treatment.

This study is currently active. If you would like more information on this study please contact Joan Aylor, Research Coordinator, at 216.445.1698.

Focal Epilepsy Sleep Clinical Trial
Searching for "Sleep Friendly" Therapies for a sleep population: A Double-Blind, Placebo-Controlled randomized trial to assess the effects of Lacosamide on sleep and wake in adults with Focal Epilepsy

Sleepiness and fatigue are the most common complaints of people with epilepsy and can have a negative impact on quality of life. Though unproven, these problems are often blamed on anti-seizure medications. Cleveland Clinic investigators are studying the impact of the newest anti-seizure medication Lacosamide (Vimpat®) on sleep and wakefulness in adults with focal (partial onset) seizures.

Focal epilepsy, also called partial epilepsy, is a disorder in which seizures are preceded by an isolated disturbance such as a twitching of a part of the body, a particular sensation or feeling, or some other disturbance in consciousness. The study is open to adults 18 and older with focal seizures.

Participation involves a physical exam, sleep testing at the Sleep Center, blood tests, completion of study questionnaires/diaries, and a random assignment to either take the study drug or placebo (often called a “look alike” or “sugar pill”) for 5 to 8 weeks. There are 5 study visits and participants will receive compensation for time spent in the study.

If you would like more information on this study please contact:
Nancy Foldvary-Schaefer, DO, Cleveland Clinic Sleep Disorders Center at 216.445.2990

Oxidative Stress in Sleep Apnea and Cardiac Disease

(NIH/NHLBI HL079114 K23 Mentored Patient-Oriented Clinical Research Career Development Award, 2006-2011, PI: R Mehra) The goal is to assess changes in oxidative stress and intermediate cardiovascular measures including vascular stiffness in patients with sleep-disordered breathing who receive CPAP and sham CPAP in a randomized parallel design study.

This study is in analysis phase. If you would like more information on this study please contact Joan Aylor, Research Coordinator, at 216.445.1698.

Phase II Trial of Sleep Apnea Treatment to Reduce Cardiovascular Morbidity

(1RC2HL101417-01, 2009-2012 NHLBI, PI: S Redline, Site PI: R Mehra, Co-Director Electrophysiology Core: R Mehra): The study aims to evaluate the utility of a novel application of nocturnal supplemental oxygen in treating patients at high risk for cardiovascular disease (CVD) events with sleep apnea. This will identify which pathophysiological pathways may be improved by blunting the physiological stress of intermittent hypoxemia compared to improving airway patency. The study will lay the ground work for a definitive Phase 3 study that will address the role of sleep apnea interventions in CVD risk reduction.

This study is in analysis phase. If you would like more information on this study please contact Joan Aylor, Research Coordinator, at 216.445.1698.

Sleep-Related Respiratory and Electrophysiological Atrial Fibrillation Predictors

(NHLBI 1 R21 HL108226-01A1, PI: R Mehra). Perform detailed analysis of the baseline ECG and respiratory data collected from ~3000 MrOS Sleep Study participants and relate these markers of electrical stability (p/t wave propagation) and respiratory related phenotypes to incident arrhythmia.

This study is currently active. If you would like more information on this study please contact Joan Aylor, Research Coordinator, at 216.445.1698.

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