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Sleep Apnea clinical trials

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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NCT ID: NCT02557412 Withdrawn - Sleep Apnea Clinical Trials

Effect of Nasal CPAP on Lipid Profile in Patients With Dyslipidaemia and Sleep Apnea

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

OBJECTIVES Main objective: To assess if six months of treatment with CPAP, associated with conventional treatment, improves the lipid profile of patients with dyslipidemia and mild-moderate apnea-hypopnea syndrome (OSA). Secondary objectives: - Determine the additional effect of CPAP on insulin resistance and dyslipidemia in patients with mild-moderate OSA. - Assess the impact of CPAP treatment in reducing cardiovascular risk in patients with dyslipidemia and mild-moderate OSA. DESIGN Randomized, parallel group, non-blind, controlled clinical trial with conventional treatment. STUDY POPULATION 35-75 year old subjects, diagnosed with dyslipidemia in last six months and in stable treatment during the last month with diet, cholesterol lowering drug, and cholesterol LDL levels> 100 mg / dl in the last two successive visits clinics. Sample size. 38 patients who completed the test in each treatment arm. TREATMENT Patients will be randomized to one of the following treatment arms form: 1. hygiene and dietary recommendations. 2. lifestyle intervention (more strict and promotion of daily physical activity and dietary control). 3. Treatment with positive airway pressure (CPAP). ENDPOINTS: Efficacy endpoints. - Primary endpoint: LDL-cholesterol. - Total cholesterol, HDL-cholesterol, triglycerides and C-reactive protein high sensitivity (hsCRP). - Systemic Biomarkers: inflammatory (IL-6, IL-8 and tumor necrosis factor (TNF)-α), oxidative stress (8-isoprostane), endothelial damage (endothelin, vascular cell adhesion molecule 1 (VCAM-1) and Intercellular Adhesion Molecule 1 (ICAM-1)), sympathetic activity (neuropeptide Y) and appetite-regulating hormones (leptin, orexin A / hypocretin-1 and ghrelin). - Fasting glucose, glycated hemoglobin (HbA1c), fasting insulin and Homeostasis Model Assessment (HOMA) index and quantitative insulin sensitivity check index (QUICKI), thyroid-stimulating hormone (TSH). - Clinical questionnaires: short-form (SF)-12, EuroQoL, Functional Outcomes of Sleep Questionnaire (FOSQ) and International physical activity questionnaire (IPAQ). Security endpoints. - Notification of clinical adverse events. - Compliance with CPAP (average hours use per day). - Epworth Sleepiness Questionnaire. - Development of cardiovascular events.

NCT ID: NCT02552303 Active, not recruiting - Insomnia Clinical Trials

The Treatment of Insomnia Comorbid With Sleep Disordered Breathing Using Armodafinil and/or Cognitive Behavioral Therapy for Insomnia

Start date: April 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effects of Armodafinil, CBT-I, or the combination of the two on the sleep continuity of persons suffering from sleep disordered breathing and their adherence to CBT-I and Continuous Positive Airway Pressure (CPAP). Adults diagnosed with obstructive sleep apnea and who meet additional research and diagnostic criteria for insomnia will be recruited. Participants will submit daily sleep diaries and supplemental questionnaires as measures of study progress.

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: NCT02506166 Not yet recruiting - Heart Failure Clinical Trials

European Sleep Apnea and Sudden CArdiac Death ProjEct

ESCAPE-SCD
Start date: January 2016
Phase: N/A
Study type: Interventional

The objective of ESCAPE-SCD Study is assessment of the effect of sleep apnea on sudden cardiac death risk and cardiovascular outcomes in patients with ischemic cardiomyopathy. The ESCAPE - SCD Study will address following specific study questions: - Is obstructive sleep apnea (OSA) and/or central sleep apnea (CSA) an independent risk factor of sudden cardiac death (SCD) in patients with ischemic cardiomyopathy (ICM) indicated for ICD/CRT-D implant based on current European Society of Cardiology (ESC) Guidelines for primary prevention of sudden cardiac death? - Can treatment of predominant (>50%) obstructive sleep apnea by appropriate Positive Airway Pressure (PAP) therapy decrease risk of sudden cardiac arrhythmic death in ICM patients? - Can treatment of predominant (>50%) obstructive sleep apnea by appropriate PAP therapy improve cardiovascular outcomes in ICM patients indicated for ICD/CRT-D implant? - Does obstructive sleep apnea represent a novel factor that may improve risk stratification of sudden cardiac death and advance identification of those patients that will benefit from ICD/CRT-D therapy?

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: NCT02442999 Terminated - Sleep Apnea Clinical Trials

The SNORES Randomized Clinical Trial

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

Randomized clinical trial among women with polycystic ovary syndrome (PCOS) who present for fertility treatment to evaluate the impact of screening for obstructive sleep apnea.

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.

NCT ID: NCT02426424 Withdrawn - Stroke Clinical Trials

Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients

Start date: January 2018
Phase: Phase 4
Study type: Interventional

This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation. The study will enroll 140 subjects which will be randomized into one of two arms: - Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge. - Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.

NCT ID: NCT02387476 Completed - Clinical trials for Obstructive Sleep Apnea

Non-Inferiority Study of the FRESCA Mask Versus Existing CPAP Mask for Treatment of Obstructive Sleep Apnea

Start date: October 2014
Phase: N/A
Study type: Interventional

This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.