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Sleep Apnea clinical trials

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NCT ID: NCT02751021 Completed - Sleep Apnea Clinical Trials

Sleep Apnea Diagnosis Using a Novel Pacemaker Algorithm and Link With Aldosterone Plasma Level in Patients Presenting With Diastolic Dysfunction

SAPAAD
Start date: June 22, 2016
Phase: N/A
Study type: Interventional

Little is known about potential relationships between sleep apnea, plasma aldosterone and diastolic dysfunction which is a very frequent finding among patients requiring permanent cardiac pacing. Sleep apnea is often under diagnosed by clinical examination. Confirmation tests are expensive and access is limited. A specific algorithm available in a recent pacemaker allows assessing breathing variations using minute ventilation sensor, with a good agreement between the respiratory disturbance index and polysomnography results for the diagnosis of severe sleep apnea. The purpose of the study is to examine the diagnostic accuracy of a new pacemaker algorithm for the diagnosis of obstructive sleep apnea in patients presenting with diastolic dysfunction. The investigators also aim to highlight a correlation between plasma aldosterone levels and the severity of sleep apnea, with a reversal effect of ventilation therapy in this specific population.

NCT ID: NCT02748681 Completed - Stroke Clinical Trials

Telemedicine Monitoring of Sleep Apnea in Stroke

HOPES
Start date: April 2016
Phase: N/A
Study type: Interventional

Study Objectives: Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in stroke patients, with adherence rates for CPAP therapy of only 30%. The primary objective of this study is to determine whether CPAP adherence in stroke patients with obstructive sleep apnea can be improved by a CPAP training strategy during rehabilitation combined with a telemedicine monitoring system after discharge. The secondary objective is to compare recording quality as well as subjective and objective sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in the management of sleep apnea in stroke. Further the investigators aim to study changes in nocturnal systolic blood pressure due to CPAP therapy with the pulse transit time method. Finally, the investigators intend to study the relationship between CPAP compliance, sleep and medical and neurorehabilition outcome parameters. Design: Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to severe OSA. Setting: Neurorehabilitation center in Vienna, Austria Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal AHI< 10) at the neurorehabilitation unit. Interventions: Patients will be randomized to either standard care with an autotitrating CPAP device or an autotitrating CPAP device that transmits physiologic information (i.e., adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare provider. If any problems are identified, the patient will be contacted by his homecare provider by telephone. Neurologists performing sleep and neurological scoring will be blinded to the randomization. Measurements: Recording of the different measuring systems, subjective and objective sleep quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP determined by means of a non-linear algorithm and an individual one-point calibration of the pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany) and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.

NCT ID: NCT02727192 Completed - Sleep Apnea Clinical Trials

Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation

Start date: January 21, 2016
Phase: N/A
Study type: Interventional

Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades. The occurrence of AF is associated with significantly increased mortality as well as morbidity of which cerebrovascular accidents is the most important. Unfortunately treatment options remain limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential for toxicity and adverse events are recognized. Recent year's catheter ablation of AF continues to gain acceptance for symptomatic treatment, but recurrence rate are high with need for continuous medication. Thus there is a need to better understand what causes development and triggers episodes of AF as well to introduce new treatment options. Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore gained interest. Many patients with AF have chronic sleep apnea, and in the present study the investigators want to explore the interaction between SA and AF. The hypothesis of the present study is that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis the investigators will implant a Reveal device that continuously records the hearts rhythm of 100 patients with paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be examined, and the patients will then be randomized to treatment of SA or not and the influence on total AF burden recorded both before and after ablation.

NCT ID: NCT02701504 Completed - Sleep Apnea Clinical Trials

Undiagnosed Sleep Apnea and Bypass OperaTion

SABOT
Start date: October 1, 2013
Phase:
Study type: Observational

Sleep apnea is a prevalent disorder in patients with coronary artery disease. Previous studies suggested sleep apnea was associated with coronary plaque burden and future adverse cardiovascular events after percutaneous coronary intervention. In the SABOT study, the investigators used a FDA-approved portable sleep device to diagnose sleep apnea, and evaluate the relationship between sleep apnea and cardiovascular outcomes after non-urgent coronary artery bypass surgery.

NCT ID: NCT02596087 Completed - Stroke Clinical Trials

Improving Quality by Maintaining Accurate Problems in the EHR

IQ-MAPLE
Start date: April 2016
Phase: N/A
Study type: Interventional

The overall goal of the IQ-MAPLE project is to improve the quality of care provided to patients with several heart, lung and blood conditions by facilitating more accurate and complete problem list documentation. In the first aim, the investigators will design and validate a series of problem inference algorithms, using rule-based techniques on structured data in the electronic health record (EHR) and natural language processing on unstructured data. Both of these techniques will yield candidate problems that the patient is likely to have, and the results will be integrated. In Aim 2, the investigators will design clinical decision support interventions in the EHRs of the four study sites to alert physicians when a candidate problem is detected that is missing from the patient's problem list - the clinician will then be able to accept the alert and add the problem, override the alert, or ignore it entirely. In Aim 3, the investigators will conduct a randomized trial and evaluate the effect of the problem list alert on three endpoints: alert acceptance, problem list addition rate and clinical quality.

NCT ID: NCT02576587 Completed - Atrial Fibrillation Clinical Trials

Influence of Sleep Apnea on Risk of Atrial Fibrillation

Safebeat
Start date: January 1, 2012
Phase: N/A
Study type: Interventional

The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study. The study involves a case control design to investigate the extent to which there is an independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and controls as those without AF. In order to rigorously address important biologic confounding influences, the cases and controls will be individually matched based upon age, gender, race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical Research Unit (CRU) for collection of the same measures collected at the baseline exam to observe for any significant changes with the purpose of collecting effect size data to inform future clinical trials. The total duration of the study is 4 years. The duration for any individual participant is up to from one to 13 weeks months, including a 3-month treatment period for those with moderate to severe SDB, i.e. AHI>15.

NCT ID: NCT02564068 Completed - Sleep Apnea Clinical Trials

Oxytocin on HR in Sleep Apnea Patient

Start date: May 22, 2015
Phase: Early Phase 1
Study type: Interventional

In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. OSA is a very prevalent disease with high cardiovascular risk factors, yet this disease remains very poorly treated. This proposal, based on the current literature and new basic science results detailed above on the role of oxytocin in cardiovascular control, will test if oxytocin administration improves adverse cardiovascular events during the recurrent nocturnal apneas in patients with OSA. This project will lay the groundwork and provide preliminary data to obtain NIH funding to test this important hypotheses more thoroughly and in larger clinical trials. This study will explore if intranasal oxytocin has any positive cardiovascular benefits in patients with sleep apnea.

NCT ID: NCT02509247 Completed - Sleep Apnea Clinical Trials

Telemonitoring in CPAP Treatment

TeleCPAP
Start date: August 2012
Phase: N/A
Study type: Interventional

Wireless telemonitoring was used during the habituation phase of continuous positive airway pressure (CPAP) treatment in obstructive sleep apnoea (OSA) patients. Patients were allocated either to the telemonitoring group (n=50) or the usual care group (n=61). Nursing time, patient satisfaction and treatment efficiency and efficacy were compared between the groups at baseline and after one year treatment the CPAP adherence and treatment efficacy were recorded.

NCT ID: NCT02454153 Completed - Diabetes Clinical Trials

Hyperglycemic Profiles in Obstructive Sleep Apnea: Effects of PAP Therapy

HYPNOS
Start date: December 2014
Phase: N/A
Study type: Interventional

This is a randomized control trial in people with diabetes and obstructive sleep apnea who will be randomly assigned for 3 months to PAP therapy along with healthy lifestyle and sleep education or healthy lifestyle and sleep education.

NCT ID: NCT02438137 Completed - Clinical trials for Obstructive Sleep Apnea

Dimethyl Fumarate for Obstructive Sleep Apnea

Start date: May 2015
Phase: N/A
Study type: Interventional

The overall purpose of this study is to determine whether the oral medication dimethyl fumarate is an effective treatment for obstructive sleep apnea in patients who are unable, unwilling, or uneager to use positive airway pressure therapy.